ARCTIC SUN STAT
Report
- Report Number
- 1018233-2024-05086
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Date of Event
- August 2, 2024
- Report Date
- September 27, 2024
- Manufacturer
- MEDIVANCE, INC. ¿ 1725056
- Product Code
- DWJ
- UDI-DI
- 00801741161513
- PMA / PMN Number
- K200225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS OVERFILL. ARCTIC SUN DEVICE HAD ALERTED MULTIPLE TIMES WITH ALERT 113(REDUCED WATER TEMPERATURE CONTROL) WHILE TRYING TO COOL PATIENT. PATIENT TEMPERATURE (PT) 32.4C, TARGET TEMPERATURE (TT) 33.5C. WATER TEMPERATURE (WT) 24.7C, WATER FLOW RATE (WFR) 1.2 L/M. NEONATAL PADS IN USE. SYSTEM DIAGNOSTICS: OUTLET MONITOR TEMPERATURE(T1) 25.5C, OUTLET CONTROL TEMPERATURE(T2) 25.5C, INLET TEMPERATURE(T3) 25.5C, CHILLER TEMPERATURE(T4) 9.1C, WATER FLOW RATE (WFR) 1.2 L/M, INLET PRESSURE (IP) -7.2 PSI, CIRCULATION PUMP COMMAND (CPC) 36 PERCENTAGE, MIXING PUMP COMMAND (MPC) 0, HEATER 100, WATER RESERVOIR LEVEL (WRL) 5, SYSTEM HOURS 2161, PUMP HOURS 945. WALKED THROUGH STOP THERAPY AND EMPTY PADS. HAD NURSE DRAIN 16 OUNCES OF WATER FROM DEVICE. RESTARTED THERAPY. CALLED BACK 30 MINUTES LATER, WATER TEMPERATURE (WT) 40C AND PATIENT TEMPERATURE (PT) RESPONDING WELL. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION NOT TO BE MANUFACTURING RELATED THE INSTRUCTIONS-FOR-USE UNDER BAW2800736 REV. 0 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 "APPROXIMATELY FOUR LITERS OF STERILE WATER WILL BE REQUIRED TO FILL THE RESERVOIR AT INITIAL INSTALLATION. FILL THE RESERVOIR WITH STERILE WATER ONLY. WHEN FILLING THE CONTROL MODULE DURING INITIAL INSTALLATION OR WHEN COMPLETELY EMPTY, ADD ONE VIAL OF ARCTIC SUN¿ TEMPERATURE MANAGEMENT SYSTEM ARCTIC SUN CLEANING SOLUTION TO THE STERILE WATER. IT IS RECOMMENDED TO ADD THE VIAL WHEN FILLING WITH THE SECOND LITER OF STERILE WATER. 1) FROM THE PATIENT THERAPY SELECTION SCREEN, SELECT THE BUTTON NEXT TO EITHER NORMOTHERMIA OR HYPOTHERMIA UNDER THE NEW PATIENT HEADING. SELECT ANY PAD TYPE TO CONTINUE. 2) FROM THE HYPOTHERMIA OR NORMOTHERMIA THERAPY SCREEN, PRESS THE FILL RESERVOIR BUTTON. 3) THE FILL RESERVOIR SCREEN WILL APPEAR. FOLLOW THE DIRECTIONS ON THE SCREEN. 4) THE FILLING PROCESS WILL AUTOMATICALLY STOP WHEN THE RESERVOIR IS FULL. CONTINUE TO REPLACE THE BOTTLES OF STERILE WATER UNTIL THE FILLING PROCESS STOPS. 5) WHEN THE FILL RESERVOIR PROCESS IS COMPLETE, THE SCREEN WILL CLOSE. 6) TO STOP THE PROCESS EARLY, PRESS THE STOP BUTTON. NOTE: IF THE FILLING CYCLE IS STOPPED PRIOR TO COMPLETION, THE RESERVOIR WILL NOT BE FULL AND MAY REQUIRING FILLING AFTER FEWER PATIENT THERAPIES HAVE BEEN PERFORMED. 7) PRESS THE CANCEL BUTTON TO CLOSE THE SCREEN." 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. 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 ARCTIC SUN DEVICE HAD ALERTED MULTIPLE TIMES WITH ALERT 113 (REDUCED WATER TEMPERATURE CONTROL) WHILE TRYING TO COOL PATIENT. PATIENT TEMPERATURE (PT) 32.4C, TARGET TEMPERATURE (TT) 33.5C. WATER TEMPERATURE (WT) 24.7C, WATER FLOW RATE (WFR) 1.2 L/M. NEONATAL PADS IN USE. SYSTEM DIAGNOSTICS: OUTLET MONITOR TEMPERATURE(T1) 25.5C, OUTLET CONTROL TEMPERATURE(T2) 25.5C, INLET TEMPERATURE(T3) 25.5C, CHILLER TEMPERATURE(T4) 9.1C, WATER FLOW RATE (WFR) 1.2 L/M, INLET PRESSURE (IP) -7.2 PSI, CIRCULATION PUMP COMMAND (CPC) 36 PERCENTAGE, MIXING PUMP COMMAND (MPC) 0, HEATER 100, WATER RESERVOIR LEVEL (WRL) 5, SYSTEM HOURS 2161, PUMP HOURS 945. WALKED THROUGH STOP THERAPY AND EMPTY PADS. HAD NURSE DRAIN 16 OUNCES OF WATER FROM DEVICE. RESTARTED THERAPY. CALLED BACK 30 MINUTES LATER, WATER TEMPERATURE (WT) 40C AND PATIENT TEMPERATURE (PT) RESPONDING WELL. SN (B)(6).
IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD ALERTED MULTIPLE TIMES WITH ALERT 113(REDUCED WATER TEMPERATURE CONTROL) WHILE TRYING TO COOL PATIENT. PATIENT TEMPERATURE(PT) 32.4C, TARGET TEMPERATURE(TT) 33.5C. WATER TEMPERATURE(WT) 24.7C, WATER FLOW RATE(WFR) 1.2 L/M. NEONATAL PADS IN USE. SYSTEM DIAGNOSTICS: OUTLET MONITOR TEMPERATURE(T1) 25.5C, OUTLET CONTROL TEMPERATURE(T2) 25.5C, INLET TEMPERATURE(T3) 25.5C, CHILLER TEMPERATURE(T4) 9.1C, WATER FLOW RATE (WFR) 1.2 L/M, INLET PRESSURE(IP) -7.2 PSI, CIRCULATION PUMP COMMAND(CPC) 36 PERCENTAGE, MIXING PUMP COMMAND(MPC) 0, HEATER 100, WATER RESERVOIR LEVEL(WRL) 5, SYSTEM HOURS 2161, PUMP HOURS 945. WALKED THROUGH STOP THERAPY AND EMPTY PADS. HAD NURSE DRAIN 16 OUNCES OF WATER FROM DEVICE. RESTARTED THERAPY. CALLED BACK 30 MINUTES LATER, WATER TEMPERATURE(WT) 40C AND PATIENT TEMPERATURE(PT) RESPONDING WELL. SN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28969 | ARCTIC SUN STAT | ARCTIC SUN DEVICE | DWJ | MEDIVANCE, INC. ¿ 1725056 | NA | 00801741161513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |