ARCTIC SUN DEVICE
This device is manufactured by CR BARD (COVINGTON) -1018233, MEDIVANCE 1725056.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Convulsion/Seizure | 2 | Patient |
| 2024 | Chills | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 30 | Patient |
| 2024 | Use of Device Problem | 1 | Device |
| 2024 | Restricted Flow rate | 19 | Device |
| 2024 | Pumping Problem | 23 | Device |
| 2024 | Power Problem | 3 | Device |
| 2024 | Overheating of Device | 8 | Device |
| 2024 | Overfill | 1 | Device |
| 2024 | Operating System Becomes Nonfunctional | 6 | Device |
| 2024 | Nonstandard Device | 2 | Device |
| 2024 | Material Twisted/Bent | 1 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Material Fragmentation | 5 | Device |
| 2024 | Lack of Effect | 14 | Device |
| 2024 | Insufficient Heating | 14 | Device |
| 2024 | Insufficient Cooling | 53 | Device |
| 2024 | Incorrect Measurement | 1 | Device |
| 2024 | Inaccurate Flow Rate | 31 | Device |
| 2024 | Gas/Air Leak | 19 | Device |
| 2024 | Fracture | 2 | Device |
| 2024 | Fluid/Blood Leak | 1 | Device |
| 2024 | Fitting Problem | 2 | Device |
| 2024 | Failure to Pump | 54 | Device |
| 2024 | Failure to Calibrate | 14 | Device |
| 2024 | Electrical Shorting | 1 | Device |
| 2024 | Device Sensing Problem | 33 | Device |
| 2024 | Device Alarm System | 2 | Device |
| 2024 | Defective Component | 37 | Device |
| 2024 | Decreased Pump Speed | 23 | Device |
| 2024 | Computer Software Problem | 1 | Device |
| 2024 | Computer Operating System Problem | 9 | Device |
| 2024 | Circuit Failure | 12 | Device |
| 2024 | Calibration Problem | 11 | Device |
| 2024 | Alarm Not Visible | 2 | Device |
| 2023 | Electric Shock | 1 | Patient |
| 2023 | Convulsion/Seizure | 1 | Patient |
| 2023 | Chills | 9 | Patient |
| 2023 | Appropriate Term / Code Not Available | 70 | Patient |
| 2023 | Use of Device Problem | 2 | Device |
| 2023 | Restricted Flow rate | 41 | Device |
| 2023 | Pumping Problem | 28 | Device |
| 2023 | Power Problem | 1 | Device |
| 2023 | Physical Resistance/Sticking | 2 | Device |
| 2023 | Overheating of Device | 12 | Device |
| 2023 | Overfill | 4 | Device |
| 2023 | Operating System Becomes Nonfunctional | 19 | Device |
| 2023 | Nonstandard Device | 4 | Device |
| 2023 | No Display/Image | 1 | Device |
| 2023 | Moisture Damage | 1 | Device |
| 2023 | Missing Information | 1 | Device |
| 2023 | Material Twisted/Bent | 2 | Device |
| 2023 | Material Split, Cut or Torn | 2 | Device |
| 2023 | Material Fragmentation | 3 | Device |
| 2023 | Lack of Effect | 7 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Insufficient Heating | 55 | Device |
| 2023 | Insufficient Cooling | 105 | Device |
| 2023 | Incorrect Measurement | 1 | Device |
| 2023 | Inaccurate Flow Rate | 45 | Device |
| 2023 | Improper or Incorrect Procedure or Method | 5 | Device |
| 2023 | Gas/Air Leak | 55 | Device |
| 2023 | Fluid/Blood Leak | 2 | Device |
| 2023 | Fitting Problem | 1 | Device |
| 2023 | Failure to Pump | 83 | Device |
| 2023 | Failure to Calibrate | 27 | Device |
| 2023 | Erratic or Intermittent Display | 1 | Device |
| 2023 | Electrical Shorting | 2 | Device |
| 2023 | Disconnection | 1 | Device |
| 2023 | Device Sensing Problem | 54 | Device |
| 2023 | Device Dislodged or Dislocated | 1 | Device |
| 2023 | Device Alarm System | 1 | Device |
| 2023 | Defective Component | 88 | Device |
| 2023 | Decreased Pump Speed | 54 | Device |
| 2023 | Computer Operating System Problem | 8 | Device |
| 2023 | Component Misassembled | 1 | Device |
| 2023 | Circuit Failure | 27 | Device |
| 2023 | Alarm Not Visible | 1 | Device |
| 2022 | Appropriate Term / Code Not Available | 7 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Solder Joint Fracture | 2 | Device |
| 2022 | Restricted Flow rate | 34 | Device |
| 2022 | Pumping Problem | 14 | Device |
| 2022 | Power Problem | 1 | Device |
| 2022 | Patient Device Interaction Problem | 1 | Device |
| 2022 | Partial Blockage | 3 | Device |
| 2022 | Overheating of Device | 12 | Device |
| 2022 | Overfill | 4 | Device |
| 2022 | Operating System Becomes Nonfunctional | 15 | Device |
| 2022 | Nonstandard Device | 33 | Device |
| 2022 | Misassembly During Maintenance/Repair | 1 | Device |
| 2022 | Material Twisted/Bent | 1 | Device |
| 2022 | Material Split, Cut or Torn | 3 | Device |
| 2022 | Material Fragmentation | 5 | Device |
| 2022 | Insufficient Information | 2 | Device |
| 2022 | Insufficient Heating | 35 | Device |
| 2022 | Insufficient Cooling | 54 | Device |
| 2022 | Inaccurate Flow Rate | 22 | Device |
| 2022 | Improper or Incorrect Procedure or Method | 4 | Device |
| 2022 | Gas/Air Leak | 46 | Device |
| 2022 | Fracture | 3 | Device |
| 2022 | Fluid/Blood Leak | 2 | Device |
| 2022 | Failure to Pump | 67 | Device |
| 2022 | Failure to Calibrate | 32 | Device |
| 2022 | Electrical Shorting | 3 | Device |
| 2022 | Device Sensing Problem | 34 | Device |
| 2022 | Device Handling Problem | 2 | Device |
| 2022 | Device Dislodged or Dislocated | 2 | Device |
| 2022 | Defective Component | 49 | Device |
| 2022 | Decreased Pump Speed | 36 | Device |
| 2022 | Computer Software Problem | 5 | Device |
| 2022 | Computer Operating System Problem | 3 | Device |
| 2022 | Component Missing | 3 | Device |
| 2022 | Component Misassembled | 2 | Device |
| 2022 | Circuit Failure | 15 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Misassembly by Users | 1 | Device |
| 2021 | Inadequate or Insufficient Training | 1 | Device |
| 2021 | Failure to Pump | 2 | Device |
| 2021 | Device Sensing Problem | 1 | Device |
| 2021 | Defective Component | 2 | Device |
| 2021 | Decreased Pump Speed | 3 | Device |
| 2020 | Patient-Device Incompatibility | 1 | Device |
| 2020 | Inaccurate Flow Rate | 2 | Device |
| 2020 | Device Displays Incorrect Message | 1 | Device |
| 2020 | Defective Component | 2 | Device |
| 2020 | Circuit Failure | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |