UNKNOWN ARCTIC SUN TEMPERATURE CABLE
Report
- Report Number
- 1018233-2025-01848
- Event Type
- Malfunction
- Date Received
- March 20, 2025
- Date of Event
- March 14, 2025
- Report Date
- August 13, 2025
- Manufacturer
- MEDIVANCE, INC. ¿ 1725056
- Product Code
- DWJ
- PMA / PMN Number
- K161602
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
THE DEVICE WAS NOT RETURNED. THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IT WAS REPORTED THAT THE BIOMED TRYING TO TROUBLESHOOT ARCTIC SUN DEVICE THAT WAS GIVING LOW FLOW. THEY TRIED TO TRANSFER TO TECH SUPPORT, BUT THEY STOPPED AND ASKED HOW TO CHECK THE EVENT LOG (THEY SEEMED UNFAMILIAR WITH THE DEVICE). EVENT LOG DID NOT SHOW ANY LOW FLOW ALERTS. ASKED IF THEY HAD DONE A CALIBRATION AND STATED THEIR CTU NEEDS TO BE CALIBRATED. WALKED THROUGH ENABLING MANUAL CONTROL AT 4C AND GUIDED TO SYSTEM DIAGNOSTICS, SYSTEM HOURS 2976, PUMP HOURS 2833, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 49 PERCENTAGE, FLOW RATE (FR) WAS 1.7LPM. EXPLAINED THEY SHOULD CALL IF WATER TEMPERATURE (WT) WAS NOT REACH 4C. IF IT DOES, CHANGE THE MANUAL CONTROL SCREEN TO 40C AND INCREASE TIME TO 30 MINUTES AGAIN. CALL BACK IF WATER TEMPERATURE (WT) DOES NOT INCREASE TO 40C. TRANSFERRED TO ESS TO GET THE CTU CALIBRATED. THE INSTRUCTIONS-FOR-USE 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 DHR REVIEW IS NOT REQUIRED AS THE SERIAL NUMBER IS UNKNOWN. 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 THE BIOMED TRYING TO TROUBLESHOOT ARCTIC SUN DEVICE THAT WAS GIVING LOW FLOW. THEY TRIED TO TRANSFER TO TECH SUPPORT, BUT THEY STOPPED AND ASKED HOW TO CHECK THE EVENT LOG (THEY SEEMED UNFAMILIAR WITH THE DEVICE). EVENT LOG DID NOT SHOW ANY LOW FLOW ALERTS. EVENT LOG SHOWED, 045 (ALERT) - AC POWER LOST, 14 (ALARM) - PROBE OUT OF RANGE, 27 (ALARM) - TEMPERATURE PROBE 2 OUT OF RANGE, 116 ¿ PATIENT TEMPERATURE NOT CHANGED (ALERT), 117 ¿ PATIENT TEMPERATURE NOT CHANGED (ALARM). ASKED IF THEY HAD DONE A CALIBRATION AND STATED THEIR CTU NEEDS TO BE CALIBRATED. WALKED THROUGH ENABLING MANUAL CONTROL AT 4C AND GUIDED TO SYSTEM DIAGNOSTICS, SYSTEM HOURS 2976, PUMP HOURS 2833, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 49 PERCENTAGE, FLOW RATE (FR) WAS 1.7LPM. EXPLAINED THEY SHOULD CALL IF WATER TEMPERATURE (WT) WAS NOT REACH 4C. IF IT DOES, CHANGE THE MANUAL CONTROL SCREEN TO 40C AND INCREASE TIME TO 30 MINUTES AGAIN. CALL BACK IF WATER TEMPERATURE (WT) DOES NOT INCREASE TO 40C. TRANSFERRED TO ESS TO GET THE CTU CALIBRATED.
IT WAS REPORTED THAT THE BIOMED TRYING TO TROUBLESHOOT ARCTIC SUN DEVICE THAT WAS GIVING LOW FLOW. THEY TRIED TO TRANSFER TO TECH SUPPORT, BUT THEY STOPPED AND ASKED HOW TO CHECK THE EVENT LOG (THEY SEEMED UNFAMILIAR WITH THE DEVICE). EVENT LOG DID NOT SHOW ANY LOW FLOW ALERTS. EVENT LOG SHOWED, 045 (ALERT) - AC POWER LOST, 14 (ALARM) - PROBE OUT OF RANGE, 27 (ALARM) - TEMPERATURE PROBE 2 OUT OF RANGE, 116 ¿ PATIENT TEMPERATURE NOT CHANGED (ALERT), 117 ¿ PATIENT TEMPERATURE NOT CHANGED (ALARM). ASKED IF THEY HAD DONE A CALIBRATION AND STATED THEIR CTU NEEDS TO BE CALIBRATED. WALKED THROUGH ENABLING MANUAL CONTROL AT 4C AND GUIDED TO SYSTEM DIAGNOSTICS, SYSTEM HOURS 2976, PUMP HOURS 2833, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 49 PERCENTAGE, FLOW RATE (FR) WAS 1.7LPM. EXPLAINED THEY SHOULD CALL IF WATER TEMPERATURE (WT) WAS NOT REACH 4C. IF IT DOES, CHANGE THE MANUAL CONTROL SCREEN TO 40C AND INCREASE TIME TO 30 MINUTES AGAIN. CALL BACK IF WATER TEMPERATURE (WT) DOES NOT INCREASE TO 40C. TRANSFERRED TO ESS TO GET THE CTU CALIBRATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1177647 | UNKNOWN ARCTIC SUN TEMPERATURE CABLE | ARCTIC SUN TEMPERATURE CABLE | DWJ | MEDIVANCE, INC. ¿ 1725056 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |