TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
This device is manufactured by ABIOMED.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Split, Cut or Torn |
| 2024-07-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-12 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-07-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance |
| 2024-07-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance |
| 2024-07-09 | Injury | Hemolysis, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-07-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2024-07-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2024-06-30 | Injury | Thrombosis/Thrombus | Infusion or Flow Problem |
| 2024-06-30 | Injury | Thrombosis/Thrombus | Restricted Flow rate |
| 2024-06-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-06-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Split, Cut or Torn |
| 2024-06-28 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-06-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-06-28 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-06-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Patient-Device Incompatibility |
| 2024-06-27 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-06-26 | Injury | Hemorrhage/Blood Loss/Bleeding | None |
| 2024-06-24 | Injury | Hemorrhage/Blood Loss/Bleeding | None |
| 2024-06-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-06-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-06-20 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-06-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2024-06-18 | Malfunction | Thrombosis/Thrombus | Malposition of Device |
| 2024-06-18 | Injury | Hemorrhage/Blood Loss/Bleeding, Ectopic Heartbeat | Adverse Event Without Identified Device or Use Problem |
| 2024-06-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-06-17 | Death | Great Vessel Perforation | Adverse Event Without Identified Device or Use Problem |
| 2024-06-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Split, Cut or Torn |
| 2024-06-14 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-06-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate |
| 2024-06-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Read Input Signal |
| 2024-06-12 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-06-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-06-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Split, Cut or Torn |
| 2024-06-11 | Injury | Hemorrhage/Blood Loss/Bleeding, Ectopic Heartbeat | Adverse Event Without Identified Device or Use Problem |
| 2024-06-11 | Injury | Hemolysis | None |
| 2024-06-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2024-06-10 | Injury | Hemolysis | Restricted Flow rate, Detachment of Device or Device Component |
| 2024-06-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Patient-Device Incompatibility |
| 2024-06-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-06-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2024-06-09 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-06-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-06-07 | Injury | Hematoma | Malposition of Device |
| 2024-06-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Prime |
| 2024-06-06 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-06-05 | Death | Thrombosis/Thrombus | Positioning Failure |
| 2024-06-04 | Injury | Hematoma, Ventricular Fibrillation | Adverse Event Without Identified Device or Use Problem |
| 2024-06-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-06-03 | Injury | Hematoma | Detachment of Device or Device Component |
| 2024-06-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-06-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-06-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2024-06-02 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-06-02 | Injury | Stroke/CVA, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-06-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-05-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-05-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility, Difficult to Advance |
| 2024-05-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-05-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-05-30 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2024-05-30 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-05-30 | Injury | Ischemia | Adverse Event Without Identified Device or Use Problem |
| 2024-05-29 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-05-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate |
| 2024-05-27 | Injury | Arrhythmia | Fluid/Blood Leak |
| 2024-05-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-05-24 | Injury | Stroke/CVA, Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2024-05-24 | Injury | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2024-05-23 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-05-22 | Death | Perforation | Adverse Event Without Identified Device or Use Problem |
| 2024-05-22 | Injury | Hemolysis, Hematuria | Restricted Flow rate |
| 2024-05-21 | Injury | Embolism/Embolus | Adverse Event Without Identified Device or Use Problem |
| 2024-05-21 | Injury | Hemorrhage/Blood Loss/Bleeding, Unspecified Vascular Problem | Adverse Event Without Identified Device or Use Problem |
| 2024-05-21 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-05-20 | Malfunction | Cardiovascular Insufficiency | Increase in Pressure |
| 2024-05-20 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-05-20 | Injury | Hemorrhage/Blood Loss/Bleeding, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2024-05-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility, Difficult to Advance |
| 2024-05-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Migration or Expulsion of Device |
| 2024-05-18 | Injury | Hemorrhage/Blood Loss/Bleeding | Fluid/Blood Leak, Difficult to Insert |
| 2024-05-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2024-05-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Failure |
| 2024-05-17 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-05-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-05-16 | Injury | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2024-05-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2024-05-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2024-05-16 | Injury | Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2024-05-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Difficult to Advance |
| 2024-05-15 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-05-14 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-05-12 | Malfunction | Cardiovascular Insufficiency | Pumping Stopped, Infusion or Flow Problem |
| 2024-05-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2024-05-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2024-05-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped, Deformation Due to Compressive Stress |
| 2024-05-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2024-05-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2024-05-09 | Injury | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2024-05-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-05-09 | Injury | Arrhythmia | Adverse Event Without Identified Device or Use Problem |
| 2024-05-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Priming Problem |
| 2024-05-07 | Injury | Hemorrhage/Blood Loss/Bleeding, Cardiovascular Insufficiency | Increase in Pressure |
| 2024-05-06 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-05-06 | Injury | Hemolysis, No Clinical Signs, Symptoms or Conditions | Device Sensing Problem, Adverse Event Without Identified Device or Use Problem |
| 2024-05-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Component Incompatible, Computer Operating System Problem |
| 2024-05-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility, Difficult to Advance |
| 2024-05-02 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-05-01 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2024-05-01 | Death | Cardiac Perforation | Device Handling Problem |
| 2024-04-30 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-04-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-04-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break, Material Separation |
| 2024-04-28 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-04-28 | Injury | Arrhythmia | Restricted Flow rate |
| 2024-04-27 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-04-27 | Injury | Tachycardia, Thrombocytopenia | Malposition of Device, Material Split, Cut or Torn |
| 2024-04-27 | Injury | Stroke/CVA | Restricted Flow rate |
| 2024-04-27 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-04-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-04-26 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-04-26 | Malfunction | Cardiovascular Insufficiency | Patient-Device Incompatibility |
| 2024-04-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2024-04-24 | Injury | Hemolysis, Mitral Valve Insufficiency/ Regurgitation | Positioning Failure |
| 2024-04-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated, Positioning Problem |
| 2024-04-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Prime |
| 2024-04-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Separation, Material Perforation |
| 2024-04-24 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-04-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure, Pumping Stopped |
| 2024-04-23 | Injury | Bacterial Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-04-22 | Injury | Stroke/CVA, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-04-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Separation |
| 2024-04-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-04-22 | Injury | Tachycardia, Ventricular Fibrillation | Restricted Flow rate |
| 2024-04-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-04-20 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-04-19 | Death | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-04-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2024-04-18 | Injury | Thrombosis/Thrombus | Increase in Pressure, Pressure Problem |
| 2024-04-17 | Injury | Air Embolism, Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2024-04-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-04-16 | Injury | Air Embolism, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-04-16 | Death | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2024-04-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2024-04-13 | Injury | Ischemia Stroke, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-04-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Difficult to Advance |
| 2024-04-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Difficult to Advance |
| 2024-04-10 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-04-09 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-04-09 | Injury | Hemorrhage/Blood Loss/Bleeding | None |
| 2024-04-09 | Injury | Unspecified Kidney or Urinary Problem | Positioning Failure, Restricted Flow rate |
| 2024-04-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-04-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-07 | Injury | Ventricular Fibrillation | Adverse Event Without Identified Device or Use Problem |
| 2024-04-07 | Injury | Hemorrhage/Blood Loss/Bleeding | None |
| 2024-04-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-06 | Injury | Hemolysis, Hematuria | None |
| 2024-04-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion |
| 2024-04-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2024-04-06 | Injury | Hemorrhage/Blood Loss/Bleeding, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2024-04-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-04-05 | Death | Hemorrhage/Blood Loss/Bleeding, Perforation of Vessels | Adverse Event Without Identified Device or Use Problem |
| 2024-04-05 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-04-04 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-04-04 | Injury | Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2024-04-03 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-04-02 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-04-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2024-04-01 | Malfunction | Thrombosis/Thrombus | Improper Flow or Infusion |
| 2024-03-30 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-03-28 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2024-03-27 | Injury | Arrhythmia | None |
| 2024-03-25 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding | None |
| 2024-03-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility, Difficult to Advance |
| 2024-03-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-22 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-20 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding | None |
| 2024-03-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-19 | Injury | Hematoma | None |
| 2024-03-19 | Injury | Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2024-03-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-18 | Malfunction | Pulmonary Edema | None |
| 2024-03-18 | Injury | Ischemia Stroke | None |
| 2024-03-17 | Injury | Cardiac Perforation | None |
| 2024-03-15 | Death | Perforation of Vessels | None |
| 2024-03-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-13 | Injury | Cardiac Perforation | None |
| 2024-03-13 | Injury | Perforation of Vessels | None |
| 2024-03-12 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-03-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-10 | Injury | Cardiac Perforation | None |
| 2024-03-09 | Injury | Hematoma | None |
| 2024-03-08 | Injury | Stroke/CVA | None |
| 2024-03-07 | Death | Sepsis | None |
| 2024-03-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-06 | Injury | Thrombosis/Thrombus | None |
| 2024-03-06 | Injury | Hemolysis | None |
| 2024-03-06 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Separation, Unraveled Material |
| 2024-03-02 | Injury | Thrombosis/Thrombus | Improper Flow or Infusion |
| 2024-03-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pressure Problem |
| 2024-03-02 | Injury | Hemorrhage/Blood Loss/Bleeding | None |
| 2024-02-29 | Death | Hemolysis, Low Blood Pressure/ Hypotension, Failure of Implant, Renal Failure, Low Oxygen Saturation, Vascular Dissection, Thrombosis/Thrombus | None |
| 2024-02-29 | Injury | Stroke/CVA, Pericardial Effusion | None |
| 2024-02-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pressure Problem |
| 2024-02-29 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-02-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Separation |
| 2024-02-28 | Injury | Hemolysis, Low Blood Pressure/ Hypotension, No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2024-02-28 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-02-28 | Death | Cardiac Perforation | Activation, Positioning or Separation Problem |
| 2024-02-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-02-27 | Injury | Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2024-02-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak, Pumping Stopped |
| 2024-02-27 | Injury | Arrhythmia | None |
| 2024-02-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-02-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver |
| 2024-02-26 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-02-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility, Activation, Positioning or Separation Problem, Difficult to Advance |
| 2024-02-26 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-02-26 | Injury | Hemorrhage/Blood Loss/Bleeding, Tachycardia, Thrombocytopenia | None |
| 2024-02-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Increase in Pressure, Improper Flow or Infusion |
| 2024-02-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Insufficient Flow or Under Infusion, Pressure Problem |
| 2024-02-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pressure Problem |
| 2024-02-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break, Activation, Positioning or Separation Problem, Difficult to Advance |
| 2024-02-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion, Pressure Problem |
| 2024-02-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion, Material Twisted/Bent, Pumping Problem |
| 2024-02-24 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-02-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion, Pressure Problem |
| 2024-02-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2024-02-23 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-02-23 | Injury | Air Embolism, Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2024-02-23 | Injury | Thrombosis/Thrombus, No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem, Pressure Problem |
| 2024-02-23 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-02-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2024-02-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Insufficient Flow or Under Infusion |
| 2024-02-22 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-02-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Malposition of Device |
| 2024-02-21 | Injury | Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2024-02-21 | Injury | Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2024-02-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-02-21 | Injury | Hematoma, Undesired Nerve Stimulation | Adverse Event Without Identified Device or Use Problem |
| 2024-02-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2024-02-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2024-02-18 | Injury | No Clinical Signs, Symptoms or Conditions | Inaccurate Delivery |
| 2024-02-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2024-02-17 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-02-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Alarm System |
| 2024-02-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-02-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion |
| 2024-02-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pressure Problem |
| 2024-02-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Positioning Problem |
| 2024-02-13 | Injury | Hematoma, Nerve Damage | Adverse Event Without Identified Device or Use Problem |
| 2024-02-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Patient-Device Incompatibility |
| 2024-02-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion |
| 2024-02-12 | Injury | Ischemia, Thrombosis/Thrombus | Patient-Device Incompatibility |
| 2024-02-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Split, Cut or Torn |
| 2024-02-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem, Unintended Movement |
| 2024-02-09 | Injury | Tachycardia, Ventricular Fibrillation | Pumping Stopped, Positioning Problem |
| 2024-02-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2024-02-09 | Injury | Arrhythmia | Adverse Event Without Identified Device or Use Problem, Positioning Problem |
| 2024-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Advance |
| 2024-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure, Pumping Stopped |
| 2024-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Twisted/Bent |
| 2024-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Separation |
| 2024-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2024-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2024-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-02-06 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-02-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2024-02-05 | Injury | Atrial Fibrillation, Hemorrhage/Blood Loss/Bleeding | Material Twisted/Bent, Material Split, Cut or Torn |
| 2024-02-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Positioning Problem |
| 2024-02-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-02-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Sensing Problem |
| 2024-02-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2024-02-03 | Injury | Tachycardia | None |
| 2024-02-01 | Injury | Thrombosis/Thrombus | Increase in Pressure, Improper Flow or Infusion |
| 2024-01-29 | Injury | Stroke/CVA, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-01-29 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-01-27 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-01-23 | Injury | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2024-01-22 | Injury | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2024-01-22 | Injury | Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2024-01-22 | Death | No Clinical Signs, Symptoms or Conditions | Positioning Failure, Activation, Positioning or Separation Problem |
| 2024-01-22 | Injury | Hemorrhage/Blood Loss/Bleeding, Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2024-01-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2024-01-19 | Injury | Arrhythmia | Adverse Event Without Identified Device or Use Problem |
| 2024-01-18 | Injury | Stroke/CVA, Hematoma, Stenosis | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2024-01-17 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | Hemolysis, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2024-01-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2024-01-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Separation, Detachment of Device or Device Component |
| 2024-01-15 | Injury | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2024-01-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Increase in Pressure |
| 2024-01-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Unable to Obtain Readings |
| 2024-01-13 | Injury | Hematoma, Thrombosis/Thrombus | Positioning Problem |
| 2024-01-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Remove |
| 2024-01-11 | Injury | Abdominal Pain, Cardiac Arrest, Hemolysis, Tachycardia, Obstruction/Occlusion, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-01-11 | Injury | Thrombocytopenia | Adverse Event Without Identified Device or Use Problem |
| 2024-01-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2024-01-08 | Injury | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2024-01-03 | Malfunction | Thrombosis/Thrombus, No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2024-01-02 | Injury | Hemolysis, Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2023-12-31 | Injury | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2023-12-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2023-12-27 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-12-27 | Injury | Stroke/CVA, Ischemia | Adverse Event Without Identified Device or Use Problem |
| 2023-12-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2023-12-23 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-12-22 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-12-22 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-12-22 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-12-22 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-12-21 | Injury | Hemorrhage/Blood Loss/Bleeding, Perforation of Vessels | Adverse Event Without Identified Device or Use Problem |
| 2023-12-21 | Injury | Thrombocytopenia | Adverse Event Without Identified Device or Use Problem |
| 2023-12-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-12-21 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-12-19 | Injury | Unspecified Infection | None |
| 2023-12-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2023-12-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility, Difficult to Advance |
| 2023-12-18 | Injury | Ischemia | None |
| 2023-12-18 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-12-16 | Injury | Hemolysis, Tachycardia | None |
| 2023-12-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-12-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-12-15 | Injury | Vascular Dissection | Activation, Positioning or Separation Problem |
| 2023-12-15 | Injury | Hemorrhage/Blood Loss/Bleeding, Tachycardia | None |
| 2023-12-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2023-12-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Split, Cut or Torn |
| 2023-12-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-14 | Malfunction | Hemorrhage/Blood Loss/Bleeding | Patient-Device Incompatibility |
| 2023-12-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate |
| 2023-12-13 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-12-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-13 | Injury | Hemolysis | None |
| 2023-12-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-12-12 | Injury | Hemorrhage/Blood Loss/Bleeding | None |
| 2023-12-12 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-12-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-12-12 | Injury | Tachycardia, Ventricular Fibrillation, Thrombocytopenia | Adverse Event Without Identified Device or Use Problem |
| 2023-12-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-11 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-12-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation Problem |
| 2023-12-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-09 | Injury | Hematoma, Swelling/ Edema | Adverse Event Without Identified Device or Use Problem |
| 2023-12-08 | Injury | Perforation of Vessels | None |
| 2023-12-08 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-12-06 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding | None |
| 2023-12-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-05 | Injury | Hemolysis | None |
| 2023-12-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-04 | Injury | Renal Failure, Ventricular Fibrillation, Cardiogenic Shock | Adverse Event Without Identified Device or Use Problem |
| 2023-12-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-11-11 | Injury | Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2023-11-09 | Injury | Stroke/CVA, Tachycardia, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-11-03 | Malfunction | Thrombosis/Thrombus, No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2023-11-02 | Injury | Stroke/CVA | None |
| 2023-10-31 | Injury | Hemorrhage/Blood Loss/Bleeding, Tachycardia | Pumping Stopped, Adverse Event Without Identified Device or Use Problem |
| 2023-10-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-10-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Separation |
| 2023-10-26 | Injury | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-10-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2023-10-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2023-10-19 | Injury | Hemolysis, Ischemia | None |
| 2023-10-18 | Injury | Cardiac Perforation, Aortic Valve Insufficiency/ Regurgitation | Difficult to Remove, Detachment of Device or Device Component |
| 2023-10-17 | Injury | Stroke/CVA, Tachycardia | Improper Flow or Infusion |
| 2023-10-17 | Injury | Hematoma, Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-10-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Malposition of Device |
| 2023-10-16 | Injury | Hemorrhage/Blood Loss/Bleeding, Swelling/ Edema | Adverse Event Without Identified Device or Use Problem |
| 2023-10-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Separation |
| 2023-10-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-10-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver |
| 2023-10-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion |
| 2023-10-07 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-10-06 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-10-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2023-10-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-10-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-10-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Alarm |
| 2023-10-03 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-10-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Migration |
| 2023-10-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Material Twisted/Bent |
| 2023-10-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Material Twisted/Bent |
| 2023-10-02 | Injury | Thrombosis/Thrombus | Improper Flow or Infusion |
| 2023-10-02 | Injury | Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2023-10-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-09-30 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-09-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-09-28 | Injury | Hemorrhage/Blood Loss/Bleeding, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-09-28 | Injury | Hemorrhage/Blood Loss/Bleeding, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-09-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Integrity Problem |
| 2023-09-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2023-09-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-09-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility, Difficult to Advance |
| 2023-09-22 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-09-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2023-09-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2023-09-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Blocked Connection |
| 2023-09-21 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-09-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure, Improper Flow or Infusion |
| 2023-09-20 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-09-18 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-09-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure, Pumping Stopped |
| 2023-09-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-09-16 | Injury | Stroke/CVA, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-09-15 | Injury | Air Embolism, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-09-15 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding, Thrombocytopenia, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-09-14 | Injury | Hemorrhage/Blood Loss/Bleeding | Pumping Stopped |
| 2023-09-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2023-09-13 | Malfunction | Thrombosis/Thrombus | Restricted Flow rate, Increase in Pressure, Pumping Stopped |
| 2023-09-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2023-09-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-09-10 | Injury | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2023-09-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak, Increase in Pressure |
| 2023-09-08 | Injury | Hemorrhage/Blood Loss/Bleeding, Ischemia | Adverse Event Without Identified Device or Use Problem, Positioning Problem |
| 2023-09-08 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-09-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Puncture/Hole |
| 2023-09-07 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-09-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak, Increase in Pressure |
| 2023-09-06 | Injury | Hematoma, Thrombosis/Thrombus | Improper Flow or Infusion |
| 2023-09-06 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-09-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Twisted/Bent |
| 2023-09-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Infusion or Flow Problem |
| 2023-09-04 | Malfunction | Hemorrhage/Blood Loss/Bleeding, No Clinical Signs, Symptoms or Conditions | Leak/Splash, Material Split, Cut or Torn |
| 2023-09-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Positioning Problem |
| 2023-08-28 | Injury | Stroke/CVA, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-08-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-08-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-08-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Device Sensing Problem |
| 2023-08-25 | Injury | Arrhythmia, Renal Impairment | Adverse Event Without Identified Device or Use Problem |
| 2023-08-24 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-08-24 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2023-08-22 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-08-21 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-08-21 | Injury | Cardiomyopathy, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-08-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Infusion or Flow Problem |
| 2023-08-21 | Injury | Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2023-08-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped, Improper Flow or Infusion |
| 2023-08-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-08-19 | Injury | Stroke/CVA, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-08-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-08-18 | Injury | Sepsis, Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2023-08-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2023-08-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pressure Problem |
| 2023-08-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2023-08-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion |
| 2023-08-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility |
| 2023-08-05 | Injury | Nervous System Injury | Adverse Event Without Identified Device or Use Problem |
| 2023-08-05 | Death | Cardiac Arrest | Pumping Stopped |
| 2023-08-03 | Injury | Hemorrhage/Blood Loss/Bleeding | Difficult to Advance, Improper Flow or Infusion |
| 2023-08-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Separation, Inadequate User Interface |
| 2023-08-03 | Injury | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2023-08-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Leak/Splash |
| 2023-08-02 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-08-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Flush |
| 2023-08-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2023-08-01 | Injury | Swelling/ Edema | Adverse Event Without Identified Device or Use Problem |
| 2023-07-30 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-07-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pressure Problem |
| 2023-07-28 | Injury | Stroke/CVA | Infusion or Flow Problem |
| 2023-07-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Material Twisted/Bent |
| 2023-07-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Split, Cut or Torn |
| 2023-07-27 | Death | No Clinical Signs, Symptoms or Conditions | Excess Flow or Over-Infusion |
| 2023-07-27 | Injury | Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2023-07-26 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-07-26 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-07-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Material Twisted/Bent |
| 2023-07-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2023-07-20 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-07-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Unfold or Unwrap, Material Split, Cut or Torn |
| 2023-07-18 | Injury | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2023-07-18 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-07-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-07-15 | Injury | Ventricular Fibrillation | Adverse Event Without Identified Device or Use Problem |
| 2023-07-15 | Injury | Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2023-07-13 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-07-12 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-07-11 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-07-10 | Injury | Arrhythmia, Tachycardia | Positioning Problem |
| 2023-07-08 | Injury | Hemolysis | Improper Flow or Infusion, Positioning Problem |
| 2023-07-08 | Injury | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2023-07-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-07-06 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-07-06 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2023-07-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-07-04 | Injury | Embolism/Embolus | Air/Gas in Device |
| 2023-07-03 | Injury | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-06-30 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-06-30 | Injury | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate |
| 2023-06-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-06-29 | Injury | Atrial Fibrillation, Tachycardia | None |
| 2023-06-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Sensing Problem |
| 2023-06-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Sensing Problem, Improper Flow or Infusion |
| 2023-06-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Material Twisted/Bent |
| 2023-06-21 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-06-14 | Injury | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2023-06-14 | Injury | Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2023-06-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-06-12 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2023-06-12 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-06-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-06-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-06-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-06-09 | Injury | Low Blood Pressure/ Hypotension | Adverse Event Without Identified Device or Use Problem |
| 2023-06-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-06-05 | Injury | Ischemia, Retroperitoneal Hemorrhage | Adverse Event Without Identified Device or Use Problem |
| 2023-06-02 | Injury | Thrombosis/Thrombus | Positioning Problem |
| 2023-06-02 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-05-29 | Injury | Thrombocytopenia | Adverse Event Without Identified Device or Use Problem |
| 2023-05-26 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-05-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2023-05-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Twisted/Bent |
| 2023-05-22 | Injury | Hematoma, Hemolysis, Tachycardia, Renal Impairment | Adverse Event Without Identified Device or Use Problem |
| 2023-05-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Insufficient Flow or Under Infusion |
| 2023-05-16 | Injury | Hemorrhage/Blood Loss/Bleeding, Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2023-05-03 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-05-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-05-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion, Pressure Problem |
| 2023-05-02 | Injury | Aortic Valve Insufficiency/ Regurgitation | Adverse Event Without Identified Device or Use Problem |
| 2023-04-30 | Injury | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2023-04-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-04-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-04-26 | Injury | Thromboembolism | Adverse Event Without Identified Device or Use Problem |
| 2023-04-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-04-24 | Injury | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-04-20 | Injury | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2023-04-19 | Injury | Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2023-04-18 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-04-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Power Up, Pumping Stopped |
| 2023-04-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2023-04-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-04-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-04-12 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2023-04-12 | Injury | Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2023-04-10 | Injury | Thrombocytopenia, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-04-08 | Injury | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-04-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Material Twisted/Bent |
| 2023-04-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-04-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Material Twisted/Bent |
| 2023-04-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pressure Problem |
| 2023-04-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Infusion or Flow Problem |
| 2023-04-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Advance |
| 2023-04-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-03-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-03-29 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-03-25 | Death | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2023-03-22 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2023-03-22 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2023-03-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pressure Problem |
| 2023-03-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pressure Problem |
| 2023-03-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Increase in Pressure |
| 2023-03-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Device Sensing Problem |
| 2023-03-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-03-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pressure Problem |
| 2023-03-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Increase in Pressure |
| 2023-03-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2023-03-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pressure Problem |
| 2023-03-08 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-03-05 | Injury | No Clinical Signs, Symptoms or Conditions | Crack, Pumping Stopped, Improper Flow or Infusion |
| 2023-03-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-03-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Puncture/Hole, Material Integrity Problem |
| 2023-03-03 | Injury | Hemorrhage/Blood Loss/Bleeding, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2023-02-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Increase in Pressure |
| 2023-02-24 | Injury | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2023-02-24 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-02-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-02-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2023-02-21 | Injury | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2023-02-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-02-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-02-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2023-02-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2023-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-02-07 | Injury | Aortic Valve Insufficiency/ Regurgitation | Adverse Event Without Identified Device or Use Problem |
| 2023-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2023-02-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2023-02-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2023-01-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-01-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2023-01-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2023-01-24 | Injury | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2023-01-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Material Twisted/Bent |
| 2023-01-23 | Malfunction | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2023-01-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2023-01-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Air/Gas in Device |
| 2023-01-13 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2023-01-11 | Injury | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2023-01-06 | Malfunction | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-01-06 | Injury | Hemorrhage/Blood Loss/Bleeding, Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2022-12-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion |
| 2022-12-30 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-12-29 | Injury | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2022-12-29 | Injury | Hemorrhage/Blood Loss/Bleeding | Difficult or Delayed Positioning |
| 2022-12-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2022-12-28 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-12-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2022-12-22 | Injury | Aneurysm | Adverse Event Without Identified Device or Use Problem |
| 2022-12-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2022-12-21 | Injury | Hemolysis, Renal Impairment | Adverse Event Without Identified Device or Use Problem |
| 2022-12-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Advance, Material Twisted/Bent |
| 2022-12-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2022-12-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Infusion or Flow Problem |
| 2022-12-02 | Injury | Hemorrhagic Stroke | None |
| 2022-11-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2022-11-30 | Malfunction | Hemolysis, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-11-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2022-11-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2022-11-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2022-11-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2022-11-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2022-11-21 | Injury | Hemolysis, Hematuria | Adverse Event Without Identified Device or Use Problem |
| 2022-11-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2022-11-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert |
| 2022-11-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert |
| 2022-11-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-10-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2022-10-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-10-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-10-27 | Injury | Tachycardia | Fluid/Blood Leak |
| 2022-10-26 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2022-10-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-24 | Malfunction | None | Increase in Pressure, Pumping Stopped |
| 2022-10-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-10-22 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-10-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2022-10-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-10-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Advance, Material Twisted/Bent |
| 2022-10-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-10-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert |
| 2022-10-19 | Injury | Ventricular Fibrillation, No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Adverse Event Without Identified Device or Use Problem |
| 2022-10-19 | Malfunction | None | Pumping Stopped |
| 2022-10-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break, Fluid/Blood Leak |
| 2022-10-17 | Malfunction | None | Pumping Stopped |
| 2022-10-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation Failure |
| 2022-10-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2022-10-15 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-10-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2022-10-13 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2022-10-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak, Material Puncture/Hole |
| 2022-10-12 | Injury | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion |
| 2022-10-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-10-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2022-10-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Patient-Device Incompatibility |
| 2022-10-04 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-10-03 | Injury | Thrombosis/Thrombus | Restricted Flow rate, Improper Flow or Infusion, Adverse Event Without Identified Device or Use Problem |
| 2022-10-03 | Malfunction | None | Pumping Stopped |
| 2022-10-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-09-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-09-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2022-09-27 | Malfunction | None | Fracture |
| 2022-09-25 | Injury | Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2022-09-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-23 | Injury | Ischemia | Adverse Event Without Identified Device or Use Problem |
| 2022-09-22 | Injury | Hemorrhagic Stroke | None |
| 2022-09-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2022-09-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion |
| 2022-09-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-09-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2022-09-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-09-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2022-09-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion |
| 2022-09-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-09-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2022-09-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2022-09-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2022-09-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2022-08-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2022-08-23 | Injury | Stroke/CVA, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-08-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Increase in Pressure |
| 2022-08-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Positioning Problem |
| 2022-08-04 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2022-08-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Advance, Material Twisted/Bent |
| 2022-07-29 | Injury | Gastrointestinal Hemorrhage | Adverse Event Without Identified Device or Use Problem |
| 2022-07-28 | Malfunction | None | Leak/Splash, Pumping Stopped |
| 2022-07-25 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2022-07-21 | Injury | Ischemia | Adverse Event Without Identified Device or Use Problem |
| 2022-07-21 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-07-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Migration |
| 2022-07-17 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2022-07-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Sensing Problem |
| 2022-07-14 | Injury | Perforation of Vessels | Adverse Event Without Identified Device or Use Problem |
| 2022-07-12 | Injury | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2022-07-11 | Injury | Ventricular Fibrillation | None |
| 2022-07-08 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2022-07-08 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-07-05 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-07-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate |
| 2022-07-03 | Injury | Hemorrhage/Blood Loss/Bleeding | None |
| 2022-07-01 | Injury | Vascular Dissection | Difficult to Advance |
| 2022-06-30 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-06-30 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-06-29 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2022-06-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Patient-Device Incompatibility |
| 2022-06-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2022-06-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, Patient-Device Incompatibility |
| 2022-06-18 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-06-17 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-06-14 | Injury | Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2022-06-14 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-06-12 | Malfunction | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2022-06-11 | Injury | Hematoma, Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2022-06-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2022-06-01 | Injury | Hematoma | Positioning Problem |
| 2022-05-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Failure |
| 2022-05-29 | Injury | Ventricular Fibrillation | Adverse Event Without Identified Device or Use Problem |
| 2022-05-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Sensing Problem |
| 2022-05-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Sensing Problem, Improper Flow or Infusion |
| 2022-05-21 | Injury | Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2022-05-19 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-05-19 | Injury | Thrombocytopenia | Improper Flow or Infusion |
| 2022-05-19 | Injury | Hematoma, Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2022-05-19 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2022-05-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2022-05-16 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-05-10 | Injury | Hemorrhage/Blood Loss/Bleeding | Positioning Problem |
| 2022-05-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2022-05-06 | Injury | Hemorrhage/Blood Loss/Bleeding, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-05-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2022-04-30 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-04-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak, Material Split, Cut or Torn |
| 2022-04-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2022-04-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2022-04-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Patient-Device Incompatibility |
| 2022-04-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2022-04-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak, Fracture |
| 2022-04-17 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-04-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion |
| 2022-04-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Inaccurate Flow Rate, Fluid/Blood Leak |
| 2022-04-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Increase in Pressure |
| 2022-04-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2022-04-10 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2022-04-07 | Injury | Ischemia, Thrombosis/Thrombus | Increase in Pressure |
| 2022-04-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Patient-Device Incompatibility |
| 2022-04-05 | Injury | Hemorrhage/Blood Loss/Bleeding, Ischemia | Adverse Event Without Identified Device or Use Problem |
| 2022-04-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2022-03-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Patient-Device Incompatibility |
| 2022-03-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Sensing Intermittently |
| 2022-03-18 | Injury | Tachycardia | Adverse Event Without Identified Device or Use Problem |
| 2022-03-09 | Injury | Atrial Fibrillation | Adverse Event Without Identified Device or Use Problem |
| 2022-03-08 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-02-28 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Sensing Problem |
| 2022-02-22 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2022-02-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Patient-Device Incompatibility |
| 2022-02-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break, Image Display Error/Artifact |
| 2022-02-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2022-01-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2022-01-17 | Injury | Stroke/CVA, Perforation of Vessels | Adverse Event Without Identified Device or Use Problem |
| 2022-01-16 | Injury | Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2022-01-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2022-01-11 | Injury | Hemolysis, Hemorrhage/Blood Loss/Bleeding, Ischemia, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-01-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2022-01-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2021-12-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2021-12-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2021-12-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Positioning Problem |
| 2021-12-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-12-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2021-12-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2021-12-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2021-12-15 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2021-12-13 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2021-12-13 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2021-12-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2021-12-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Remove |
| 2021-12-10 | Injury | Hematoma, Ischemia | Adverse Event Without Identified Device or Use Problem |
| 2021-12-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2021-11-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2021-11-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2021-11-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Crack, Fluid/Blood Leak |
| 2021-11-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2021-11-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-11-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Deformation Due to Compressive Stress |
| 2021-11-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2021-11-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2021-11-10 | Injury | Tachycardia, Ventricular Fibrillation | Adverse Event Without Identified Device or Use Problem |
| 2021-11-09 | Injury | Ventricular Fibrillation | Failure to Deliver, Adverse Event Without Identified Device or Use Problem |
| 2021-11-08 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2021-11-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-11-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Crack, Fluid/Blood Leak |
| 2021-11-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-11-04 | Death | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2021-10-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Advance |
| 2021-10-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem, Difficult to Advance |
| 2021-10-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate |
| 2021-10-28 | Injury | Ischemia, Pain, Thrombocytopenia | Adverse Event Without Identified Device or Use Problem |
| 2021-10-28 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2021-10-26 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2021-10-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped |
| 2021-10-23 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2021-10-21 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2021-10-20 | Injury | Hemorrhage/Blood Loss/Bleeding, No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion, Adverse Event Without Identified Device or Use Problem |
| 2021-10-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break, Fluid/Blood Leak |
| 2021-10-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2021-10-14 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2021-10-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Deformation Due to Compressive Stress |
| 2021-10-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2021-10-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2021-10-11 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2021-10-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2021-10-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2021-10-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Crack, Fluid/Blood Leak |
| 2021-10-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Crack, Fluid/Blood Leak |
| 2021-09-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Deliver, Patient-Device Incompatibility |
| 2021-09-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Improper Flow or Infusion |
| 2021-09-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Difficult to Setup or Prepare, Patient-Device Incompatibility |
| 2021-09-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-09-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2021-09-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2021-09-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Deformation Due to Compressive Stress |
| 2021-09-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Deformation Due to Compressive Stress |
| 2021-09-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2021-09-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-09-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-09-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Crack |
| 2021-09-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2021-09-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-09-09 | Malfunction | Hemorrhage/Blood Loss/Bleeding, No Clinical Signs, Symptoms or Conditions | Device Fell |
| 2021-09-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Crack, Pumping Stopped |
| 2021-08-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-08-28 | Injury | Hemolysis | Adverse Event Without Identified Device or Use Problem |
| 2021-08-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-08-27 | Injury | Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2021-08-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-08-19 | Injury | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2021-08-19 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2021-08-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Crack |
| 2021-08-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult or Delayed Positioning, Deformation Due to Compressive Stress |
| 2021-08-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-08-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2021-08-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-08-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-08-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2021-08-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult or Delayed Positioning, Material Deformation |
| 2021-08-07 | Injury | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2021-07-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem |
| 2021-07-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-07-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-07-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-07-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Patient-Device Incompatibility, Difficult to Advance |
| 2021-07-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult or Delayed Positioning, Activation, Positioning or Separation Problem |
| 2021-07-17 | Injury | Hemorrhage/Blood Loss/Bleeding, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2021-07-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-07-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-07-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-07-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak, Pressure Problem |
| 2021-07-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pumping Stopped, Device Sensing Problem, Material Integrity Problem |
| 2021-07-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Improper Flow or Infusion |
| 2021-07-01 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2021-06-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2021-06-28 | Injury | Hemorrhage/Blood Loss/Bleeding, Ventricular Fibrillation | Adverse Event Without Identified Device or Use Problem |
| 2021-06-25 | Injury | Hemolysis, Renal Impairment | None |
| 2021-06-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak |
| 2021-05-24 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2021-05-14 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2021-04-13 | Injury | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2021-04-12 | Injury | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2021-04-12 | Injury | Hemorrhage/Blood Loss/Bleeding, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2021-04-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak, Air/Gas in Device |
| 2021-04-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation, Positioning or Separation Problem |
| 2021-04-03 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2019-09-17 | Malfunction | None | Device Alarm System, Alarm Not Visible |