ARCTIC SUN® 5000
Report
- Report Number
- 1018233-2025-01617
- Event Type
- Malfunction
- Date Received
- March 11, 2025
- Date of Event
- March 6, 2025
- Report Date
- July 24, 2025
- Manufacturer
- MEDIVANCE, INC. ¿ 1725056
- Product Code
- DWJ
- UDI-DI
- 00801741080142
- PMA / PMN Number
- K161602
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION: D, E, F, H. INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. A REVIEW OF THE RISK DOCUMENT, FMEA RA2800010 REV 25, WAS PERFORMED FOR THIS INVESTIGATION. THE REPORTED EVENT IS ADDRESSED IN STEP #RA13. BASED ON THIS REVIEW THE RISK IS WITHIN THE EXPECTED RANGE. THE LABELING/IFU REVISION ACCOMPANYING THIS SERIAL NUMBER IS NOT RECORDED IN THE DHR. THE LATEST LABELING REVISION WILL BE REVIEWED FOR THIS INVESTIGATION. THE INSTRUCTIONS-FOR-USE UNDER BAW2800548 REV 3 AND BAW2800424 REV 2 ARE FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
IT WAS REPORTED THAT THEY WERE INITIATING THERAPY USING AN ARCTIC SUN DEVICE BUT WERE GETTING ALERT 02 (LOW FLOW). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.4PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. PUMP HOURS WERE 6778.8 AND SYSTEM HOURS WERE 7355. ASKED NURSE TO STOP THERAPY, EMPTY AND DISCONNECT PADS. ENABLED MANUAL MODE. NO VISIBLE DAMAGE TO FLUID DELIVERY LINE (FDL) AND IT WAS FULLY SEATED. IN MANUAL WITHOUT PADS FLOW RATE (FR) WAS 1.6LPM, INLET PRESSURE (IP) WAS -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 57 PERCENTAGE. CONNECTED LEFT THIGH PAD. FLOW RATE (FR) WAS 0.7LPM, INLET PRESSURE (IP) WAS -7.3PSI, 34 PERCENTAGE. CONNECTED LEFT CHEST PAD. 0LPM, -0.9PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. VALUES DID NOT IMPROVE WHEN MOVING TO ANOTHER VALVE SET. FLOW RATE (FR) REMAINED 0LPM AND INLET PRESSURE (IP) WAS -0PSI WHEN CONNECTING RIGHT PADS. SUGGESTED REPLACING PADS, LOT NGJX2427. WALKED THROUGH DISABLING MANUAL CONTROL. ASKED NURSE TO PUT PADS BEHIND NURSING STATION IF THEY WANT THEM RETURNED TO QUALITY FOR INSPECTION.
IT WAS REPORTED THAT THEY WERE INITIATING THERAPY USING AN ARCTIC SUN DEVICE BUT WERE GETTING ALERT 02 (LOW FLOW). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.4PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. PUMP HOURS WERE 6778.8 AND SYSTEM HOURS WERE 7355. ASKED NURSE TO STOP THERAPY, EMPTY AND DISCONNECT PADS. ENABLED MANUAL MODE. NO VISIBLE DAMAGE TO FLUID DELIVERY LINE (FDL) AND IT WAS FULLY SEATED. IN MANUAL WITHOUT PADS FLOW RATE (FR) WAS 1.6LPM, INLET PRESSURE (IP) WAS -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 57 PERCENTAGE. CONNECTED LEFT THIGH PAD. FLOW RATE (FR) WAS 0.7LPM, INLET PRESSURE (IP) WAS -7.3PSI, 34 PERCENTAGE. CONNECTED LEFT CHEST PAD. 0LPM, -0.9PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. VALUES DID NOT IMPROVE WHEN MOVING TO ANOTHER VALVE SET. FLOW RATE (FR) REMAINED 0LPM AND INLET PRESSURE (IP) WAS -0PSI WHEN CONNECTING RIGHT PADS. SUGGESTED REPLACING PADS, LOT NGJX2427. WALKED THROUGH DISABLING MANUAL CONTROL. ASKED NURSE TO PUT PADS BEHIND NURSING STATION IF THEY WANT THEM RETURNED TO QUALITY FOR INSPECTION.
IT WAS REPORTED THAT THEY WERE INITIATING THERAPY USING AN ARCTIC SUN DEVICE BUT WERE GETTING ALERT 02 (LOW FLOW). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.4PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. PUMP HOURS WERE 6778.8 AND SYSTEM HOURS WERE 7355. ASKED NURSE TO STOP THERAPY, EMPTY AND DISCONNECT PADS. ENABLED MANUAL MODE. NO VISIBLE DAMAGE TO FLUID DELIVERY LINE (FDL) AND IT WAS FULLY SEATED. IN MANUAL WITHOUT PADS FLOW RATE (FR) WAS 1.6LPM, INLET PRESSURE (IP) WAS -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 57 PERCENTAGE. CONNECTED LEFT THIGH PAD. FLOW RATE (FR) WAS 0.7LPM, INLET PRESSURE (IP) WAS -7.3PSI, 34 PERCENTAGE. CONNECTED LEFT CHEST PAD. 0LPM, -0.9PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. VALUES DID NOT IMPROVE WHEN MOVING TO ANOTHER VALVE SET. FLOW RATE (FR) REMAINED 0LPM AND INLET PRESSURE (IP) WAS -0PSI WHEN CONNECTING RIGHT PADS. SUGGESTED REPLACING PADS, LOT NGJX2427. WALKED THROUGH DISABLING MANUAL CONTROL. ASKED NURSE TO PUT PADS BEHIND NURSING STATION IF THEY WANT THEM RETURNED TO QUALITY FOR INSPECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1203876 | ARCTIC SUN® 5000 | ARCTIC SUN DEVICE | DWJ | MEDIVANCE, INC. ¿ 1725056 | NA | 00801741080142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |