PUMP, INFUSION
This device is manufactured by CONMED, FIRST BIOMEDICAL DBA INFUSYSTEM, MEDTRONIC HEART VALVES, MEDTRONIC HEART VALVES DIVISION, SMITHS MEDICAL and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Malaise | 1 | Patient |
| 2024 | Insufficient Information | 10 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Cyanosis | 1 | Patient |
| 2024 | Cough | 1 | Patient |
| 2024 | Volume Accuracy Problem | 6 | Device |
| 2024 | Use of Incorrect Control/Treatment Settings | 1 | Device |
| 2024 | Pumping Stopped | 7 | Device |
| 2024 | Pumping Problem | 3 | Device |
| 2024 | Pressure Problem | 2 | Device |
| 2024 | Premature Discharge of Battery | 1 | Device |
| 2024 | Peeled/Delaminated | 1 | Device |
| 2024 | Partial Blockage | 2 | Device |
| 2024 | Overheating of Device | 1 | Device |
| 2024 | Obstruction of Flow | 3 | Device |
| 2024 | No Display/Image | 2 | Device |
| 2024 | No Audible Alarm | 1 | Device |
| 2024 | Naturally Worn | 1 | Device |
| 2024 | Mechanical Problem | 5 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Material Rupture | 1 | Device |
| 2024 | Material Integrity Problem | 2 | Device |
| 2024 | Loss of Data | 1 | Device |
| 2024 | Loose or Intermittent Connection | 2 | Device |
| 2024 | Key or Button Unresponsive/not Working | 4 | Device |
| 2024 | Intermittent Loss of Power | 2 | Device |
| 2024 | Insufficient Flow or Under Infusion | 8 | Device |
| 2024 | Infusion or Flow Problem | 2 | Device |
| 2024 | Increase in Pressure | 4 | Device |
| 2024 | Inaccurate Information | 1 | Device |
| 2024 | Inaccurate Delivery | 5 | Device |
| 2024 | Improper Flow or Infusion | 12 | Device |
| 2024 | Fluid/Blood Leak | 2 | Device |
| 2024 | False Alarm | 3 | Device |
| 2024 | Failure to Sense | 14 | Device |
| 2024 | Failure to Pump | 4 | Device |
| 2024 | Failure to Prime | 1 | Device |
| 2024 | Failure to Power Up | 1 | Device |
| 2024 | Failure to Infuse | 61 | Device |
| 2024 | Failure to Deliver | 2 | Device |
| 2024 | Excess Flow or Over-Infusion | 6 | Device |
| 2024 | Electrical Power Problem | 1 | Device |
| 2024 | Device Sensing Problem | 28 | Device |
| 2024 | Device Dislodged or Dislocated | 1 | Device |
| 2024 | Device Alarm System | 74 | Device |
| 2024 | Degraded | 3 | Device |
| 2024 | Defective Component | 4 | Device |
| 2024 | Connection Problem | 1 | Device |
| 2024 | Circuit Failure | 2 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Battery Problem | 7 | Device |
| 2024 | Backflow | 1 | Device |
| 2024 | Air/Gas in Device | 11 | Device |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Insufficient Information | 36 | Patient |
| 2023 | Volume Accuracy Problem | 1 | Device |
| 2023 | Unexpected Shutdown | 1 | Device |
| 2023 | Pumping Stopped | 2 | Device |
| 2023 | No Display/Image | 1 | Device |
| 2023 | No Audible Alarm | 1 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Insufficient Flow or Under Infusion | 7 | Device |
| 2023 | Infusion or Flow Problem | 1 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2023 | Inaccurate Synchronization | 2 | Device |
| 2023 | Inaccurate Flow Rate | 1 | Device |
| 2023 | Inaccurate Delivery | 4 | Device |
| 2023 | Improper Flow or Infusion | 2 | Device |
| 2023 | False Alarm | 6 | Device |
| 2023 | Failure to Run on Battery | 1 | Device |
| 2023 | Failure to Infuse | 4 | Device |
| 2023 | Excess Flow or Over-Infusion | 6 | Device |
| 2023 | Display or Visual Feedback Problem | 2 | Device |
| 2023 | Device Alarm System | 105 | Device |
| 2023 | Defective Device | 1 | Device |
| 2023 | Defective Component | 2 | Device |
| 2023 | Contamination | 1 | Device |
| 2023 | Calibration Problem | 1 | Device |
| 2023 | Battery Problem | 4 | Device |
| 2023 | Alarm Not Visible | 2 | Device |
| 2023 | Air/Gas in Device | 6 | Device |
| 2022 | Volume Accuracy Problem | 1 | Device |
| 2022 | Unintended Application Program Shut Down | 1 | Device |
| 2022 | Unexpected Shutdown | 1 | Device |
| 2022 | Priming Problem | 1 | Device |
| 2022 | Power Problem | 1 | Device |
| 2022 | Output Problem | 1 | Device |
| 2022 | Obstruction of Flow | 4 | Device |
| 2022 | No Display/Image | 2 | Device |
| 2022 | Misconnection | 1 | Device |
| 2022 | Mechanical Problem | 5 | Device |
| 2022 | Leak/Splash | 3 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Insufficient Flow or Under Infusion | 5 | Device |
| 2022 | Infusion or Flow Problem | 2 | Device |
| 2022 | Increase in Pressure | 1 | Device |
| 2022 | Inaccurate Synchronization | 2 | Device |
| 2022 | Inaccurate Delivery | 2 | Device |
| 2022 | Fluid/Blood Leak | 2 | Device |
| 2022 | False Alarm | 8 | Device |
| 2022 | Failure to Shut Off | 4 | Device |
| 2022 | Failure to Pump | 1 | Device |
| 2022 | Failure to Power Up | 19 | Device |
| 2022 | Failure to Infuse | 1 | Device |
| 2022 | Failure to Deliver | 1 | Device |
| 2022 | Excess Flow or Over-Infusion | 3 | Device |
| 2022 | Device Fell | 1 | Device |
| 2022 | Device Displays Incorrect Message | 1 | Device |
| 2022 | Device Alarm System | 149 | Device |
| 2022 | Connection Problem | 13 | Device |
| 2022 | Audible Prompt/Feedback Problem | 1 | Device |
| 2022 | Air/Gas in Device | 35 | Device |
| 2021 | Fluid/Blood Leak | 1 | Device |
| 2021 | Device Alarm System | 3 | Device |
| 2020 | Pumping Stopped | 3 | Device |
| 2020 | Output Problem | 2 | Device |
| 2020 | Infusion or Flow Problem | 3 | Device |
| 2020 | Device Alarm System | 3 | Device |
| 2020 | Calibration Problem | 1 | Device |