ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FILL TUBE
Report
- Report Number
- 1018233-2023-01470
- Event Type
- Malfunction
- Date Received
- March 7, 2023
- Date of Event
- February 13, 2023
- Report Date
- August 31, 2023
- Manufacturer
- MEDIVANCE, INC. ¿ 1725056
- Product Code
- DWJ
- UDI-DI
- 00801741080142
- PMA / PMN Number
- K161602
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE OF THE REPORTED ISSUE COULD BE DUE TO INADEQUATE SYSTEM MAINTENANCE. HOWEVER, THIS COULD NOT BE CONFIRMED. THE SERIAL NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "CLEANING AND MAINTENANCE ROUTINE CLEANING AND PREVENTIVE MAINTENANCE SHOULD BE PERFORMED ON THE ARCTIC SUN¿ TEMPERATURE MANAGEMENT SYSTEM CONTROL MODULE EVERY 6 MONTHS AT A MINIMUM. THIS CONSISTS OF CLEANING THE EXTERNAL SURFACES, ACCESSORIES AND CHILLER CONDENSER, INSPECTING THE DEVICE, AND REPLENISHING THE INTERNAL CLEANING SOLUTION THAT SUPPRESSES MICROORGANISM GROWTH IN THE WATER RESERVOIR AND HYDRAULIC CIRCUIT. SEE THE ARCTIC SUN¿ TEMPERATURE MANAGEMENT SYSTEM SERVICE MANUAL FOR ADDITIONAL INFORMATION. TO REPLENISH THE INTERNAL CLEANING SOLUTION: 1) DRAIN THE RESERVOIR. ¿ TURN CONTROL MODULE POWER OFF. ¿ ATTACH THE DRAIN LINE TO THE TWO DRAIN VALVES ON THE BACK OF THE CONTROL MODULE. PLACE THE END OF THE DRAIN LINE INTO A CONTAINER. THE WATER WILL PASSIVELY DRAIN INTO THE CONTAINER. 2) REFILL THE RESERVOIR. ¿ FROM THE HYPOTHERMIA THERAPY SCREEN OR THE NORMOTHERMIA THERAPY SCREEN, PRESS THE FILL RESERVOIR BUTTON. ¿ THE FILL RESERVOIR SCREEN WILL APPEAR. FOLLOW THE DIRECTIONS ON THE SCREEN. ¿ ADD ONE VIAL OF ARCTIC SUN¿ TEMPERATURE MANAGEMENT SYSTEM CLEANING SOLUTION TO THE FIRST BOTTLE OF STERILE WATER. ¿ THE FILLING PROCESS WILL AUTOMATICALLY STOP WHEN THE RESERVOIR IS FULL. CONTINUE TO REPLACE THE BOTTLES OF STERILE WATER UNTIL THE FILLING PROCESS STOPS. ¿ WHEN THE FILL RESERVOIR PROCESS IS COMPLETE, THE SCREEN WILL CLOSE." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.
IT WAS REPORTED THAT CUSTOMER HEALTHCARE PERSONNEL MENTIONED THAT ARCTIC SUN FILL TUBE HAD VISIBLE MOLD INSIDE OF IT. THIS WAS DISCOVERED AT THE TIME THAT DEVICE WAS ALARMING LOW FLOW. THE DEVICE WAS SENT TO BIOMED TO DETERMINE CAUSE OF LOW FLOW, BUT HEALTHCARE PERSONNEL CONCERNED THAT MOLD MIGHT BE OBSTRUCTING WATER FLOW. THIS FACILITY BIOMED DEPARTMENT DOES WATER DRAINING OR MAINTENANCE ON A 12-MONTH SCHEDULE IN WHICH OLD WATER DRAINED, NEW WATER REPLACED WITH CLEANING SOLUTION INSTEAD OF THE MANUFACTURERS RECOMMENDED 6-MONTH CLEANING SCHEDULE.
IT WAS REPORTED THAT CUSTOMER HEALTHCARE PERSONNEL MENTIONED THAT ARCTIC SUN FILL TUBE HAD VISIBLE MOLD INSIDE OF IT. THIS WAS DISCOVERED AT THE TIME THAT DEVICE WAS ALARMING LOW FLOW. THE DEVICE WAS SENT TO BIOMED TO DETERMINE CAUSE OF LOW FLOW, BUT HEALTHCARE PERSONNEL CONCERNED THAT MOLD MIGHT BE OBSTRUCTING WATER FLOW. THIS FACILITY BIOMED DEPARTMENT DOES WATER DRAINING OR MAINTENANCE ON A 12-MONTH SCHEDULE IN WHICH OLD WATER DRAINED, NEW WATER REPLACED WITH CLEANING SOLUTION INSTEAD OF THE MANUFACTURERS RECOMMENDED 6-MONTH CLEANING SCHEDULE.
IT WAS REPORTED THAT CUSTOMER HEALTHCARE PERSONNEL MENTIONED THAT ARCTIC SUN FILL TUBE HAD VISIBLE MOLD INSIDE OF IT. THIS WAS DISCOVERED AT THE TIME THAT DEVICE WAS ALARMING LOW FLOW. THE DEVICE WAS SENT TO BIOMED TO DETERMINE CAUSE OF LOW FLOW, BUT HEALTHCARE PERSONNEL CONCERNED THAT MOLD MIGHT BE OBSTRUCTING WATER FLOW. THIS FACILITY BIOMED DEPARTMENT DOES WATER DRAINING OR MAINTENANCE ON A 12-MONTH SCHEDULE IN WHICH OLD WATER DRAINED, NEW WATER REPLACED WITH CLEANING SOLUTION INSTEAD OF THE MANUFACTURERS RECOMMENDED 6-MONTH CLEANING SCHEDULE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62914 | ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FILL TUBE | FILL TUBE | DWJ | MEDIVANCE, INC. ¿ 1725056 | 50000000 | UNK | 00801741080142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |