ARCTIC SUN® 5000
Report
- Report Number
- 1018233-2025-10666
- Event Type
- Malfunction
- Date Received
- December 2, 2025
- Date of Event
- November 20, 2025
- Report Date
- January 6, 2026
- Manufacturer
- MEDIVANCE -1725056
- Product Code
- DWJ
- UDI-DI
- 00801741080142
- PMA / PMN Number
- K161602
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS UNCONFIRMED. THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE DEVICE WAS EVALUATED UPON RECEIPT. THE COOLING ISSUE WAS FOUND TO BE NOT CONFIRMED. SERVICING OF THE CIRCULATION PUMP, MIXING PUMP, REPLACING THE EVAPORATOR OUTLET TUBE, REPLACING THE DOUBLE-BEND TUBE, REPLACING THE HEATER (LOT#2109 WITH LOT#2532), REPLACING THE DRAIN VALVES AND REPLACING THE MANIFOLD O-RINGS. LOCTITE 262 (EXPIRATION:20NOV25) WAS USED TO SECURE THE PUMP HEADS TO THE MOTORS. COIN CELL WAS REPLACED (LOT#2116 WITH LOT#231222) DUE TO AGE. THE ARCTIC SUN WAS FUNCTIONALLY TESTED FOR COMPLIANCE WITH MANUFACTURER SPECIFICATIONS. AN ELECTRICAL SAFETY TEST AND CTU CALIBRATION WERE PERFORMED. A DHR REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED. A RISK REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED. A LABELING REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS ARE NEEDED. CORRECTIONS: D, H UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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. 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.
IT WAS REPORTED THAT THE BIOMED GETTING CALIBRATION ERROR 80 (WATER CHECK TIME OUT - UNABLE TO REACH CALIBRATION TEMPERATURE) ACTUAL VALUE WAS 29.18, EXPECTED VALUE WAS 6 IN AN ARCTIC SUN DEVICE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 15AUG2025, IT WAS REPORTED THAT THEY WERE CURRENTLY AWAITING A PO TO SHIP DEVICE TO BD FOR REPAIR. NO PATIENT INVOLVED AT THE TIME OF THE MALFUNCTION. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 20NOV2025, IT WAS REPORTED THAT THERE WAS ALARM 75 (NON-RECOVERABLE SYSTEM ERROR) (SYSTEM ALARM) APPEARED IN DECONTAMINATION AND ON THE SERVICE FLOOR AND DEVICE HAS WATER IN THE LEFT DRAIN PORT BUT NOT COOLING. THIS WAS INDICATIVE OF A FAILING I/O MANIFOLD HARNESS. ALARM 80 (NON-RECOVERABLE SYSTEM ERROR) (SYSTEM ALARM) UPON POWERUP. THE I/O CARD WAS RESEATED INTO THE BACKPLANE OF THE CARD CAGE, ALONG WITH THE OTHER 3 CARDS. ALARM 80 WAS UNABLE TO BE REPRODUCED AFTER RESEATING. ALARM 80 SYSTEM ERROR AND CALIBRATION ERROR 80 (WATER CHECK TIME OUT - UNABLE TO REACH CALIBRATION TEMPERATURE) ARE 2 COMPLETELY DIFFERENT ERRORS FROM 2 DIFFERENT ERROR CODE LISTS AND ARE NOT RELATED. DEVICE HAS WATER IN LEFT DRAIN PORT BUT NOT COOLING.
IT WAS REPORTED THAT THE BIOMED GETTING CALIBRATION ERROR 80 (WATER CHECK TIME OUT - UNABLE TO REACH CALIBRATION TEMPERATURE) ACTUAL VALUE WAS 29.18, EXPECTED VALUE WAS 6 IN AN ARCTIC SUN DEVICE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 15AUG2025, IT WAS REPORTED THAT THEY WERE CURRENTLY AWAITING A PO TO SHIP DEVICE TO BD FOR REPAIR. NO PATIENT INVOLVED AT THE TIME OF THE MALFUNCTION. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 20NOV2025, IT WAS REPORTED THAT THERE WAS ALARM 75 (NON-RECOVERABLE SYSTEM ERROR) (SYSTEM ALARM) APPEARED IN DECONTAMINATION AND ON THE SERVICE FLOOR AND DEVICE HAS WATER IN THE LEFT DRAIN PORT BUT NOT COOLING. THIS WAS INDICATIVE OF A FAILING I/O MANIFOLD HARNESS. ALARM 80 (NON-RECOVERABLE SYSTEM ERROR) (SYSTEM ALARM) UPON POWERUP. THE I/O CARD WAS RESEATED INTO THE BACKPLANE OF THE CARD CAGE, ALONG WITH THE OTHER 3 CARDS. ALARM 80 WAS UNABLE TO BE REPRODUCED AFTER RESEATING. ALARM 80 SYSTEM ERROR AND CALIBRATION ERROR 80 (WATER CHECK TIME OUT - UNABLE TO REACH CALIBRATION TEMPERATURE) ARE 2 COMPLETELY DIFFERENT ERRORS FROM 2 DIFFERENT ERROR CODE LISTS AND ARE NOT RELATED. DEVICE HAS WATER IN LEFT DRAIN PORT BUT NOT COOLING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2736161 | ARCTIC SUN® 5000 | ARCTIC SUN DEVICE | DWJ | MEDIVANCE -1725056 | NA | 00801741080142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |