ARCTIC SUN STAT
Report
- Report Number
- 1018233-2024-06062
- Event Type
- Malfunction
- Date Received
- September 26, 2024
- Date of Event
- September 22, 2024
- Report Date
- November 7, 2024
- Manufacturer
- MEDIVANCE, INC. ¿ 1725056
- Product Code
- DWJ
- UDI-DI
- 00801741161513
- PMA / PMN Number
- K200225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CAPTURE ADDITIONAL INFORMATION FROM A FOLLOW UP, BUT IT DOES NOT IMPACT THE INVESTIGATION FINDINGS PREVIOUSLY SUBMITTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE RISK DOCUMENTATION REVIEW A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE SOFTWARE CONTROL ERROR. HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. BABY HAD BEEN COOLING IN AN ARCTIC SUN DEVICE SINCE 920, TARGETED TEMPERATURE (TT) WAS 33.5C, PATIENT TEMPERATURE (PT) WAS 34.1C, WATER TEMPERATURE (WT) WAS 15C, FLOW RATE (FR) WAS 0.9LPM. SN # (B)(6) SPOKE WITH PATIENT'S NURSE, CHILLER TEMPERATURE (T4) WAS 5C, MIXING PUMP COMMAND WAS 18 PERCENTAGE, LOW WATER LIMIT 10C. SUGGESTED CONFIRMING TEMPERATURE WITH A SECONDARY SOURCE. DISCUSSED TACO-ING BABY IN PAD AND PLACING BABY DIRECTLY ON PAD. WATER TEMPERATURE WAS NOT COLDER IN ATTEMPT TO KEEP PATIENT FROM OVERSHOOTING. ASKED NURSE TO CONTINUE TO MONITOR AND CALL BABY IF DID NOT APPROACH TARGET SOON. OFFERED DIRECT CELL NUMBER AND NO FURTHER CALLS. 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. DHR IS NOT REQUIRED AS THIS IS EVENT NOT AN OUT-OF-BOX FAILURE AND THEREFORE IS NOT MANUFACTURING RELATED. 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.
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE RISK DOCUMENTATION REVIEW A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE SOFTWARE CONTROL ERROR. HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. BABY HAD BEEN COOLING IN AN ARCTIC SUN DEVICE SINCE 920, TARGETED TEMPERATURE (TT) WAS 33.5C, PATIENT TEMPERATURE (PT) WAS 34.1C, WATER TEMPERATURE (WT) WAS 15C, FLOW RATE (FR) WAS 0.9LPM. SN # (B)(6) SPOKE WITH PATIENT'S NURSE, CHILLER TEMPERATURE (T4) WAS 5C, MIXING PUMP COMMAND WAS 18 PERCENTAGE, LOW WATER LIMIT 10C. SUGGESTED CONFIRMING TEMPERATURE WITH A SECONDARY SOURCE. DISCUSSED TACO-ING BABY IN PAD AND PLACING BABY DIRECTLY ON PAD. WATER TEMPERATURE WAS NOT COLDER IN ATTEMPT TO KEEP PATIENT FROM OVERSHOOTING. ASKED NURSE TO CONTINUE TO MONITOR AND CALL BABY IF DID NOT APPROACH TARGET SOON. OFFERED DIRECT CELL NUMBER AND NO FURTHER CALLS. 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. DHR IS NOT REQUIRED AS THIS IS EVENT NOT AN OUT-OF-BOX FAILURE AND THEREFORE IS NOT MANUFACTURING RELATED. 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 BABY HAD BEEN COOLING IN AN ARCTIC SUN DEVICE SINCE 920, TARGETED TEMPERATURE (TT) WAS 33.5C, PATIENT TEMPERATURE (PT) WAS 34.1C (PR # (B)(4)), WATER TEMPERATURE (WT) WAS 15C, FLOW RATE (FR) WAS 0.9LPM. SN # (B)(6) SPOKE WITH PATIENT'S NURSE, CHILLER TEMPERATURE (T4) WAS 5C, MIXING PUMP COMMAND WAS 18 PERCENTAGE, LOW WATER LIMIT 10C. SUGGESTED CONFIRMING TEMPERATURE WITH A SECONDARY SOURCE. DISCUSSED TACO-ING BABY IN PAD AND PLACING BABY DIRECTLY ON PAD. WATER TEMPERATURE WAS NOT COLDER IN ATTEMPT TO KEEP PATIENT FROM OVERSHOOTING. ASKED NURSE TO CONTINUE TO MONITOR AND CALL BABY IF DID NOT APPROACH TARGET SOON. OFFERED DIRECT CELL NUMBER AND NO FURTHER CALLS. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 01NOV2024, IT WAS REPORTED THAT THE COOLING ISSUE CONTINUED AFTER RECEIVING TECHNICAL SUPPORT AND THEY HAD TO SWITCH TO ANOTHER DEVICE. THE PATIENT COMPLETED THERAPY ON AN ALTERNATE DEVICE AND THE ARTIC SUN STAT WAS SENT TO THE ONSITE BIOMED TEAM FOR EVALUATION. NO PATIENT IMPACT WAS REPORTED.
IT WAS REPORTED THAT THE BABY HAD BEEN COOLING IN AN ARCTIC SUN DEVICE SINCE 920, TARGETED TEMPERATURE (TT) WAS 33.5C, PATIENT TEMPERATURE (PT) WAS 34.1C, WATER TEMPERATURE (WT) WAS 15C, FLOW RATE (FR) WAS 0.9LPM. SN #(B)(6) SPOKE WITH PATIENT'S NURSE, CHILLER TEMPERATURE (T4) WAS 5C, MIXING PUMP COMMAND WAS 18 PERCENTAGE, LOW WATER LIMIT 10C. SUGGESTED CONFIRMING TEMPERATURE WITH A SECONDARY SOURCE. DISCUSSED TACO-ING BABY IN PAD AND PLACING BABY DIRECTLY ON PAD. WATER TEMPERATURE WAS NOT COLDER IN ATTEMPT TO KEEP PATIENT FROM OVERSHOOTING. ASKED NURSE TO CONTINUE TO MONITOR AND CALL BABY IF DID NOT APPROACH TARGET SOON. OFFERED DIRECT CELL NUMBER AND NO FURTHER CALLS.
IT WAS REPORTED THAT THE BABY HAD BEEN COOLING IN AN ARCTIC SUN DEVICE SINCE 920, TARGETED TEMPERATURE (TT) WAS 33.5C, PATIENT TEMPERATURE (PT) WAS 34.1C, WATER TEMPERATURE (WT) WAS 15C, FLOW RATE (FR) WAS 0.9LPM. SN # (B)(6) SPOKE WITH PATIENT'S NURSE, CHILLER TEMPERATURE (T4) WAS 5C, MIXING PUMP COMMAND WAS 18 PERCENTAGE, LOW WATER LIMIT 10C. SUGGESTED CONFIRMING TEMPERATURE WITH A SECONDARY SOURCE. DISCUSSED TACO-ING BABY IN PAD AND PLACING BABY DIRECTLY ON PAD. WATER TEMPERATURE WAS NOT COLDER IN ATTEMPT TO KEEP PATIENT FROM OVERSHOOTING. ASKED NURSE TO CONTINUE TO MONITOR AND CALL BABY IF DID NOT APPROACH TARGET SOON. OFFERED DIRECT CELL NUMBER AND NO FURTHER CALLS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2264290 | ARCTIC SUN STAT | ARCTIC SUN DEVICE | DWJ | MEDIVANCE, INC. ¿ 1725056 | NA | 00801741161513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |