BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN STAT

    MDR report key: 20312720 · Received September 26, 2024

    Report

    Report Number
    1018233-2024-06079
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 22, 2024
    Report Date
    January 23, 2025
    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

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    SAMPLE NOT RECEIVED. THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE WAS NOT ABLE TO BE ISOLATED. IT WAS NOTED THAT THE BABY HAD BEEN COOLING IN AN ARCTIC SUN DEVICE SINCE 920, TARGETED TEMPERATURE (TT) WAS 33.5 C, PATIENT TEMPERATURE (PT) WAS 34.1 C, WATER TEMPERATURE (WT) WAS 15 C, FLOW RATE (FR) WAS 0.9LPM. SN # (B)(6) SPOKE WITH PATIENT'S NURSE, CHILLER TEMPERATURE (T4) WAS 5 C, MIXING PUMP COMMAND WAS 18 PERCENTAGE, LOW WATER LIMIT 10C. ASKED NURSE TO CONTINUE TO MONITOR AND CALL BABY IF DID NOT APPROACH TARGET SOON. 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. 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 THE REPORTED EVENT IS NOT AN OUT OF BOX FAILURE AND THEREFORE THE REPORTED EVENT IS NOT MANUFACTURING RELATED. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS ARE NEEDED. CORRECTION: D. 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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BABY HAD BEEN COOLING IN AN ARCTIC SUN DEVICE SINCE 920, TARGETED TEMPERATURE (TT) WAS 33.5 C, PATIENT TEMPERATURE (PT) WAS 34.1 C, WATER TEMPERATURE (WT) WAS 15 C, FLOW RATE (FR) WAS 0.9LPM. SN # (B)(6) SPOKE WITH PATIENT'S NURSE, CHILLER TEMPERATURE (T4) WAS 5 C, MIXING PUMP COMMAND WAS 18 PERCENTAGE, LOW WATER LIMIT 10 C. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738588 ARCTIC SUN STAT ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741161513

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other