ARCTIC SUN® 5000
Report
- Report Number
- 1018233-2025-00929
- Event Type
- Malfunction
- Date Received
- February 14, 2025
- Date of Event
- February 10, 2025
- Report Date
- July 18, 2025
- Manufacturer
- MEDIVANCE -1725056
- Product Code
- DWJ
- UDI-DI
- 00801741127755
- PMA / PMN Number
- K161602
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. CORRECTION: D, E, F, H 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 FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE DEVICE WAS ALSO SAYING LOW FLOW, BUT THEY THOUGHT THE FLOW RATE WAS ADEQUATE FOR THE NEONATAL PAD. NOW THE DEVICE DID NOT SEEM TO BE COOLING THE PATIENT. TARGETED TEMPERATURE (TT) WAS 33.5C, PATIENT TEMPERATURE (PT) WAS 34C, WATER FLOW RATE (WFR) WAS 1.3 L/MIN, WATER TEMPERATURE (WT) WAS 13.1C. CONFIRMED PATIENT TEMPERATURE WAS 34C ON ESOPHAGEAL PROBE, NURSE CONFIRMED PROBE WAS IN PROPER PLACEMENT. NURSE STATED WATER TEMPERATURE HAS BEEN 10-13C. EXPLAINED THE COLDEST THE WATER TEMPERATURE, OR LWL, WOULD TYPICALLY ALLOW IN NICU PROTOCOL WAS 10C. THE DEVICE WAS MAKING EXTREMELY COLD WATER AND WAS TRYING TO COOL THE PATIENT TO TARGET. IT APPEARS TO BE PATIENT RELATED. CONFIRMED THE PATIENT WAS CRYING AND MOVING, EXPLAINED THIS WAS LIKELY CAUSING HEAT GENERATION WHICH WAS WHY THE PATIENT WAS HAVING A HARD TIME REACHING THE TARGET TEMPERATURE. NURSE CONFIRMED THEY HAVE A THIN RECEIVING BLANKET BETWEEN THE PAD AND THE BABY; THEY TYPICALLY DO THIS FOR ALL CASES AND HAVE BEEN TOLD THIS WAS OKAY TO DO. INFORMED NURSE THEY USUALLY RECOMMEND NOTHING BETWEEN THE PAD AND THE PATIENT¿S SKIN TO ALLOW FOR THE BEST CONTACT. MORE OPTIMAL COVERAGE WOULD ALLOW FOR BETTER TEMPERATURE MANAGEMENT. THEY ALSO RECOMMEND THE PAD WAS TACOED AROUND THE BABY. INFORMED NURSE THEY COULD NOT DETERMINE WHAT WOULD BE THE TOLERABLE RANGE THEY SHOULD ALLOW A PATIENT TEMPERATURE TO BE CONSIDERED AT TARGET. THIS WOULD BE A CLINICAL DECISION AND WOULD RECOMMEND DISCUSSING WITH THE PROVIDER. IT MIGHT VARY FOR PATIENT TO PATIENT. THE DEVICE ITSELF DID HAVE A 0.5C +/- TOLERANCE WHEN REACHING THE COOLING TARGET FOR WHEN THE DURATION TIMER WOULD BEGIN. NURSE WOULD DISCUSS WITH THE PROVIDER AND CALL BACK WITH ANY OTHER ISSUES. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 29APR2025, PER REVIEW OF EVENT, BD REPRESENTATIVE SUCCESSFULLY TROUBLESHOT THE MALFUNCTION DURING THE CALL. THE EVENT CONCLUDED WITH THE DEVICE WORKING AND THE PATIENT ON THE TRAJECTORY FOR SUCCESSFUL THERAPY COMPLETION. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE MANUFACTURING RELATED. THE INSTRUCTIONS-FOR-USE UNDER (B)(4) 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. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS ARE NEEDED. CORRECTIONS: D, E 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.
IT WAS REPORTED THAT THE NURSE ASKED HOW MUCH PLUS OR MINUS FROM THE TARGET TEMPERATURE DO THEY RECOMMEND FOR THE PATIENT TO BE CONSIDERED AT TARGET IN AN ARCTIC SUN DEVICE. NURSE HAS A PATIENT COOLING ON THE DEVICE. AT ONE POINT THE DEVICE TURNED OFF AND THEY WERE ABLE TO TURN IT BACK ON AND CONTINUE THERAPY. THE DEVICE WAS ALSO SAYING LOW FLOW, BUT THEY THOUGHT THE FLOW RATE WAS ADEQUATE FOR THE NEONATAL PAD. NOW THE DEVICE DID NOT SEEM TO BE COOLING THE PATIENT. TARGETED TEMPERATURE (TT) WAS 33.5C, PATIENT TEMPERATURE (PT) WAS 34C, WATER FLOW RATE (WFR) WAS 1.3 L/MIN, WATER TEMPERATURE (WT) WAS 13.1C. CONFIRMED PATIENT TEMPERATURE WAS 34C ON ESOPHAGEAL PROBE, NURSE CONFIRMED PROBE WAS IN PROPER PLACEMENT. NURSE STATED WATER TEMPERATURE HAS BEEN 10-13C. EXPLAINED THE COLDEST THE WATER TEMPERATURE, OR LWL, WOULD TYPICALLY ALLOW IN NICU PROTOCOL WAS 10C. THE DEVICE WAS MAKING EXTREMELY COLD WATER AND WAS TRYING TO COOL THE PATIENT TO TARGET. IT APPEARS TO BE PATIENT RELATED. CONFIRMED THE PATIENT WAS CRYING AND MOVING, EXPLAINED THIS WAS LIKELY CAUSING HEAT GENERATION WHICH WAS WHY THE PATIENT WAS HAVING A HARD TIME REACHING THE TARGET TEMPERATURE. NURSE CONFIRMED THEY HAVE A THIN RECEIVING BLANKET BETWEEN THE PAD AND THE BABY, THEY TYPICALLY DO THIS FOR ALL CASES AND HAVE BEEN TOLD THIS WAS OKAY TO DO. INFORMED NURSE THEY USUALLY RECOMMEND NOTHING BETWEEN THE PAD AND THE PATIENT¿S SKIN TO ALLOW FOR THE BEST CONTACT. MORE OPTIMAL COVERAGE WOULD ALLOW FOR BETTER TEMPERATURE MANAGEMENT. THEY ALSO RECOMMEND THE PAD WAS TACOED AROUND THE BABY. INFORMED NURSE THEY COULD NOT DETERMINE WHAT WOULD BE THE TOLERABLE RANGE THEY SHOULD ALLOW A PATIENT TEMPERATURE TO BE CONSIDERED AT TARGET. THIS WOULD BE A CLINICAL DECISION AND WOULD RECOMMEND DISCUSSING WITH THE PROVIDER. IT MIGHT VARY FOR PATIENT TO PATIENT. THE DEVICE ITSELF DID HAVE A 0.5C +/- TOLERANCE WHEN REACHING THE COOLING TARGET FOR WHEN THE DURATION TIMER WOULD BEGIN. NURSE WOULD DISCUSS WITH THE PROVIDER AND CALL BACK WITH ANY OTHER ISSUES.
IT WAS REPORTED THAT THE NURSE ASKED HOW MUCH PLUS OR MINUS FROM THE TARGET TEMPERATURE DO THEY RECOMMEND FOR THE PATIENT TO BE CONSIDERED AT TARGET IN AN ARCTIC SUN DEVICE. NURSE HAS A PATIENT COOLING ON THE DEVICE. AT ONE POINT THE DEVICE TURNED OFF AND THEY WERE ABLE TO TURN IT BACK ON AND CONTINUE THERAPY. THE DEVICE WAS ALSO SAYING LOW FLOW, BUT THEY THOUGHT THE FLOW RATE WAS ADEQUATE FOR THE NEONATAL PAD. NOW THE DEVICE DID NOT SEEM TO BE COOLING THE PATIENT. TARGETED TEMPERATURE (TT) WAS 33.5C, PATIENT TEMPERATURE (PT) WAS 34C, WATER FLOW RATE (WFR) WAS 1.3 L/MIN, WATER TEMPERATURE (WT) WAS 13.1C. CONFIRMED PATIENT TEMPERATURE WAS 34C ON ESOPHAGEAL PROBE, NURSE CONFIRMED PROBE WAS IN PROPER PLACEMENT. NURSE STATED WATER TEMPERATURE HAS BEEN 10-13C. EXPLAINED THE COLDEST THE WATER TEMPERATURE, OR LWL, WOULD TYPICALLY ALLOW IN NICU PROTOCOL WAS 10C. THE DEVICE WAS MAKING EXTREMELY COLD WATER AND WAS TRYING TO COOL THE PATIENT TO TARGET. IT APPEARS TO BE PATIENT RELATED. CONFIRMED THE PATIENT WAS CRYING AND MOVING, EXPLAINED THIS WAS LIKELY CAUSING HEAT GENERATION WHICH WAS WHY THE PATIENT WAS HAVING A HARD TIME REACHING THE TARGET TEMPERATURE. NURSE CONFIRMED THEY HAVE A THIN RECEIVING BLANKET BETWEEN THE PAD AND THE BABY, THEY TYPICALLY DO THIS FOR ALL CASES AND HAVE BEEN TOLD THIS WAS OKAY TO DO. INFORMED NURSE THEY USUALLY RECOMMEND NOTHING BETWEEN THE PAD AND THE PATIENT¿S SKIN TO ALLOW FOR THE BEST CONTACT. MORE OPTIMAL COVERAGE WOULD ALLOW FOR BETTER TEMPERATURE MANAGEMENT. THEY ALSO RECOMMEND THE PAD WAS TACOED AROUND THE BABY. INFORMED NURSE THEY COULD NOT DETERMINE WHAT WOULD BE THE TOLERABLE RANGE THEY SHOULD ALLOW A PATIENT TEMPERATURE TO BE CONSIDERED AT TARGET. THIS WOULD BE A CLINICAL DECISION AND WOULD RECOMMEND DISCUSSING WITH THE PROVIDER. IT MIGHT VARY FOR PATIENT TO PATIENT. THE DEVICE ITSELF DID HAVE A 0.5C +/- TOLERANCE WHEN REACHING THE COOLING TARGET FOR WHEN THE DURATION TIMER WOULD BEGIN. NURSE WOULD DISCUSS WITH THE PROVIDER AND CALL BACK WITH ANY OTHER ISSUES.
IT WAS REPORTED THAT THE NURSE ASKED HOW MUCH PLUS OR MINUS FROM THE TARGET TEMPERATURE DO THEY RECOMMEND FOR THE PATIENT TO BE CONSIDERED AT TARGET IN AN ARCTIC SUN DEVICE. NURSE HAS A PATIENT COOLING ON THE DEVICE. AT ONE POINT THE DEVICE TURNED OFF AND THEY WERE ABLE TO TURN IT BACK ON AND CONTINUE THERAPY. THE DEVICE WAS ALSO SAYING LOW FLOW, BUT THEY THOUGHT THE FLOW RATE WAS ADEQUATE FOR THE NEONATAL PAD. NOW THE DEVICE DID NOT SEEM TO BE COOLING THE PATIENT. TARGETED TEMPERATURE (TT) WAS 33.5C, PATIENT TEMPERATURE (PT) WAS 34C, WATER FLOW RATE (WFR) WAS 1.3 L/MIN, WATER TEMPERATURE (WT) WAS 13.1C. CONFIRMED PATIENT TEMPERATURE WAS 34C ON ESOPHAGEAL PROBE, NURSE CONFIRMED PROBE WAS IN PROPER PLACEMENT. NURSE STATED WATER TEMPERATURE HAS BEEN 10-13C. EXPLAINED THE COLDEST THE WATER TEMPERATURE, OR LWL, WOULD TYPICALLY ALLOW IN NICU PROTOCOL WAS 10C. THE DEVICE WAS MAKING EXTREMELY COLD WATER AND WAS TRYING TO COOL THE PATIENT TO TARGET. IT APPEARS TO BE PATIENT RELATED. CONFIRMED THE PATIENT WAS CRYING AND MOVING, EXPLAINED THIS WAS LIKELY CAUSING HEAT GENERATION WHICH WAS WHY THE PATIENT WAS HAVING A HARD TIME REACHING THE TARGET TEMPERATURE. NURSE CONFIRMED THEY HAVE A THIN RECEIVING BLANKET BETWEEN THE PAD AND THE BABY, THEY TYPICALLY DO THIS FOR ALL CASES AND HAVE BEEN TOLD THIS WAS OKAY TO DO. INFORMED NURSE THEY USUALLY RECOMMEND NOTHING BETWEEN THE PAD AND THE PATIENT¿S SKIN TO ALLOW FOR THE BEST CONTACT. MORE OPTIMAL COVERAGE WOULD ALLOW FOR BETTER TEMPERATURE MANAGEMENT. THEY ALSO RECOMMEND THE PAD WAS TACOED AROUND THE BABY. INFORMED NURSE THEY COULD NOT DETERMINE WHAT WOULD BE THE TOLERABLE RANGE THEY SHOULD ALLOW A PATIENT TEMPERATURE TO BE CONSIDERED AT TARGET. THIS WOULD BE A CLINICAL DECISION AND WOULD RECOMMEND DISCUSSING WITH THE PROVIDER. IT MIGHT VARY FOR PATIENT TO PATIENT. THE DEVICE ITSELF DID HAVE A 0.5C +/- TOLERANCE WHEN REACHING THE COOLING TARGET FOR WHEN THE DURATION TIMER WOULD BEGIN. NURSE WOULD DISCUSS WITH THE PROVIDER AND CALL BACK WITH ANY OTHER ISSUES. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 29APR2025, PER REVIEW OF EVENT, BD REPRESENTATIVE SUCCESSFULLY TROUBLESHOT THE MALFUNCTION DURING THE CALL. THE EVENT CONCLUDED WITH THE DEVICE WORKING AND THE PATIENT ON THE TRAJECTORY FOR SUCCESSFUL THERAPY COMPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1150794 | ARCTIC SUN® 5000 | ARCTIC SUN DEVICE | DWJ | MEDIVANCE -1725056 | NA | 00801741127755 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |