PUMP, INFUSION
This device is manufactured by SIEMENS HEALTHCARE DIAGNOSTICS, SIEMENS MEDICAL SOLUTIONS USA, SMITHS MEDICAL ASD, SMITHS MEDICAL INTERNATIONAL, SMITHS MEDICAL MD (FORMERLY DELTEC ) and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Nausea | 1 | Patient |
| 2024 | Insufficient Information | 187 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Confusion/ Disorientation | 1 | Patient |
| 2024 | Volume Accuracy Problem | 33 | Device |
| 2024 | Pumping Stopped | 1 | Device |
| 2024 | Pumping Problem | 1 | Device |
| 2024 | Pressure Problem | 4 | Device |
| 2024 | Partial Blockage | 2 | Device |
| 2024 | Overheating of Device | 2 | Device |
| 2024 | Obstruction of Flow | 6 | Device |
| 2024 | No Flow | 1 | Device |
| 2024 | No Display/Image | 1 | Device |
| 2024 | Naturally Worn | 1 | Device |
| 2024 | Mechanical Problem | 13 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Material Integrity Problem | 29 | Device |
| 2024 | Material Deformation | 5 | Device |
| 2024 | Loss of Power | 2 | Device |
| 2024 | Loss of Data | 1 | Device |
| 2024 | Loose or Intermittent Connection | 1 | Device |
| 2024 | Key or Button Unresponsive/not Working | 4 | Device |
| 2024 | Intermittent Infusion | 3 | Device |
| 2024 | Insufficient Information | 8 | Device |
| 2024 | Insufficient Flow or Under Infusion | 17 | Device |
| 2024 | Infusion or Flow Problem | 4 | Device |
| 2024 | Incomplete or Inadequate Connection | 2 | Device |
| 2024 | Inaccurate Flow Rate | 9 | Device |
| 2024 | Inaccurate Delivery | 19 | Device |
| 2024 | Improper Flow or Infusion | 7 | Device |
| 2024 | Imprecision | 1 | Device |
| 2024 | Fracture | 4 | Device |
| 2024 | Fluid/Blood Leak | 2 | Device |
| 2024 | False Alarm | 5 | Device |
| 2024 | Failure to Sense | 23 | Device |
| 2024 | Failure to Pump | 3 | Device |
| 2024 | Failure to Power Up | 2 | Device |
| 2024 | Failure to Infuse | 3 | Device |
| 2024 | Failure to Deliver | 5 | Device |
| 2024 | Failure of Device to Self-Test | 2 | Device |
| 2024 | Excessive Heating | 1 | Device |
| 2024 | Excess Flow or Over-Infusion | 12 | Device |
| 2024 | Erratic or Intermittent Display | 1 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Display or Visual Feedback Problem | 10 | Device |
| 2024 | Display Difficult to Read | 1 | Device |
| 2024 | Device Sensing Problem | 13 | Device |
| 2024 | Device Markings/Labelling Problem | 1 | Device |
| 2024 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2024 | Device Alarm System | 166 | Device |
| 2024 | Detachment of Device or Device Component | 6 | Device |
| 2024 | Dent in Material | 1 | Device |
| 2024 | Degraded | 11 | Device |
| 2024 | Defective Device | 10 | Device |
| 2024 | Defective Component | 21 | Device |
| 2024 | Defective Alarm | 2 | Device |
| 2024 | Contamination | 6 | Device |
| 2024 | Connection Problem | 8 | Device |
| 2024 | Circuit Failure | 5 | Device |
| 2024 | Charging Problem | 2 | Device |
| 2024 | Calibration Problem | 4 | Device |
| 2024 | Break | 9 | Device |
| 2024 | Blocked Connection | 2 | Device |
| 2024 | Battery Problem | 9 | Device |
| 2024 | Application Program Problem | 2 | Device |
| 2024 | Alarm Not Visible | 1 | Device |
| 2024 | Air/Gas in Device | 14 | Device |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Lethargy | 1 | Patient |
| 2023 | Insufficient Information | 59 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Decreased Appetite | 1 | Patient |
| 2023 | Cough | 1 | Patient |
| 2023 | Volume Accuracy Problem | 17 | Device |
| 2023 | Use of Device Problem | 1 | Device |
| 2023 | Pumping Stopped | 1 | Device |
| 2023 | Product Quality Problem | 6 | Device |
| 2023 | Pressure Problem | 1 | Device |
| 2023 | Power Problem | 2 | Device |
| 2023 | Partial Blockage | 1 | Device |
| 2023 | Output Problem | 1 | Device |
| 2023 | Obstruction of Flow | 7 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | No Display/Image | 3 | Device |
| 2023 | No Audible Prompt/Feedback | 2 | Device |
| 2023 | No Audible Alarm | 5 | Device |
| 2023 | Moisture Damage | 1 | Device |
| 2023 | Mechanical Problem | 5 | Device |
| 2023 | Material Integrity Problem | 7 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Low Test Results | 2 | Device |
| 2023 | Loose or Intermittent Connection | 1 | Device |
| 2023 | Intermittent Loss of Power | 1 | Device |
| 2023 | Insufficient Flow or Under Infusion | 12 | Device |
| 2023 | Infusion or Flow Problem | 2 | Device |
| 2023 | Inaccurate Flow Rate | 5 | Device |
| 2023 | Inaccurate Delivery | 18 | Device |
| 2023 | Improper Flow or Infusion | 5 | Device |
| 2023 | Fluid/Blood Leak | 1 | Device |
| 2023 | Failure to Run on Battery | 1 | Device |
| 2023 | Failure to Power Up | 1 | Device |
| 2023 | Failure to Infuse | 1 | Device |
| 2023 | Failure to Deliver | 1 | Device |
| 2023 | Failure to Calibrate | 9 | Device |
| 2023 | Failure of Device to Self-Test | 1 | Device |
| 2023 | Excess Flow or Over-Infusion | 8 | Device |
| 2023 | Display or Visual Feedback Problem | 7 | Device |
| 2023 | Device Sensing Problem | 3 | Device |
| 2023 | Device Damaged Prior to Use | 1 | Device |
| 2023 | Device Alarm System | 90 | Device |
| 2023 | Detachment of Device or Device Component | 3 | Device |
| 2023 | Degraded | 1 | Device |
| 2023 | Defective Device | 1 | Device |
| 2023 | Defective Component | 10 | Device |
| 2023 | Defective Alarm | 1 | Device |
| 2023 | Crack | 2 | Device |
| 2023 | Connection Problem | 7 | Device |
| 2023 | Computer Software Problem | 4 | Device |
| 2023 | Component Missing | 1 | Device |
| 2023 | Complete Blockage | 1 | Device |
| 2023 | Circuit Failure | 3 | Device |
| 2023 | Calibration Problem | 6 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Blocked Connection | 1 | Device |
| 2023 | Battery Problem | 5 | Device |
| 2023 | Air/Gas in Device | 10 | Device |
| 2022 | Skin Burning Sensation | 1 | Patient |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Volume Accuracy Problem | 9 | Device |
| 2022 | Use of Device Problem | 2 | Device |
| 2022 | Unexpected Shutdown | 1 | Device |
| 2022 | Undercorrection | 1 | Device |
| 2022 | Pressure Problem | 2 | Device |
| 2022 | Premature Discharge of Battery | 1 | Device |
| 2022 | Power Problem | 1 | Device |
| 2022 | Overcorrection | 1 | Device |
| 2022 | Output Problem | 5 | Device |
| 2022 | Obstruction of Flow | 14 | Device |
| 2022 | Mechanical Problem | 6 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Loss of Power | 1 | Device |
| 2022 | Insufficient Flow or Under Infusion | 7 | Device |
| 2022 | Infusion or Flow Problem | 3 | Device |
| 2022 | Inaccurate Synchronization | 4 | Device |
| 2022 | Inaccurate Information | 1 | Device |
| 2022 | Inaccurate Flow Rate | 5 | Device |
| 2022 | Inaccurate Delivery | 8 | Device |
| 2022 | Improper Flow or Infusion | 2 | Device |
| 2022 | Image Display Error/Artifact | 1 | Device |
| 2022 | Free or Unrestricted Flow | 1 | Device |
| 2022 | False Negative Result | 1 | Device |
| 2022 | False Alarm | 2 | Device |
| 2022 | Failure to Shut Off | 1 | Device |
| 2022 | Failure to Power Up | 1 | Device |
| 2022 | Failure to Deliver | 5 | Device |
| 2022 | Failure to Calibrate | 15 | Device |
| 2022 | Failure to Back-Up | 1 | Device |
| 2022 | Excess Flow or Over-Infusion | 7 | Device |
| 2022 | Electrical /Electronic Property Problem | 1 | Device |
| 2022 | Display Difficult to Read | 1 | Device |
| 2022 | Device Sensing Problem | 1 | Device |
| 2022 | Device Fell | 1 | Device |
| 2022 | Device Displays Incorrect Message | 2 | Device |
| 2022 | Device Damaged Prior to Use | 1 | Device |
| 2022 | Device Alarm System | 87 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Defective Device | 2 | Device |
| 2022 | Defective Alarm | 2 | Device |
| 2022 | Date/Time-Related Software Problem | 1 | Device |
| 2022 | Data Problem | 3 | Device |
| 2022 | Connection Problem | 17 | Device |
| 2022 | Computer Software Problem | 1 | Device |
| 2022 | Computer Operating System Problem | 5 | Device |
| 2022 | Calibration Problem | 9 | Device |
| 2022 | Break | 4 | Device |
| 2022 | Battery Problem | 4 | Device |
| 2022 | Audible Prompt/Feedback Problem | 4 | Device |
| 2022 | Air/Gas in Device | 32 | Device |
| 2021 | Appropriate Term / Code Not Available | 1 | Patient |
| 2021 | Insufficient Flow or Under Infusion | 1 | Device |
| 2021 | Infusion or Flow Problem | 1 | Device |
| 2021 | Failure to Infuse | 1 | Device |
| 2020 | Pumping Stopped | 6 | Device |
| 2020 | Pressure Problem | 1 | Device |
| 2020 | Output Problem | 2 | Device |
| 2020 | Obstruction of Flow | 3 | Device |
| 2020 | No Audible Alarm | 1 | Device |
| 2020 | Mechanical Problem | 1 | Device |
| 2020 | Material Protrusion/Extrusion | 1 | Device |
| 2020 | Excess Flow or Over-Infusion | 1 | Device |
| 2020 | Electrical /Electronic Property Problem | 1 | Device |
| 2020 | Device Difficult to Setup or Prepare | 1 | Device |
| 2020 | Device Alarm System | 9 | Device |
| 2020 | Degraded | 1 | Device |
| 2020 | Connection Problem | 1 | Device |
| 2020 | Alarm Not Visible | 1 | Device |