BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS

    MDR report key: 19237239 · Received May 3, 2024

    Report

    Report Number
    1018233-2024-02455
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 12, 2024
    Report Date
    May 9, 2024
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    10801741080088
    PMA / PMN Number
    K142702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. 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

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND FURTHER INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS. ROOT CAUSE COULD NOT BE IDENTIFIED. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE ¿THE LAMINATING FILM ROLL WAS PLACED INVERTED IN THE LAMINATOR MACHINE./ THE HYDROGEL ON THE PAD WAS REWORKED. HYDROGEL OR/AND LAMINATE FILM DO NOT MEET THE SPECIFICATION." HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY AWARE OF THE PAD ISSUE IN THE JHN NEONATAL INTENSIVE CARE UNIT (NICU). THEY CAME UPON TWO MORE SETS WITH THE SAME ISSUE THIS WEEK ON 9SE. THESE PADS DID NOT STICK EITHER, PEELED BACK ON TO THEMSELVES ON SEVERAL PADS AND AS THE WATER TEMPERATURES FLUCTUATED, THE GEL CAME OFF THE PADS AND ON TO THE PATIENT, ALMOST IN A MELTING FASHION. THEY WERE NOT SURE IF THERE HAS BEEN A DIFFERENT MANUFACTURER OVER THE LAST FEW YEARS AND THE PADS HAVE BEEN GETTING WORSE AND WORSE THAT WAS MATERIAL COMING OFF AROUND THE HOSES AND THEN PADS NOT STICKING TO THE PATIENT, BUT THIS WAS THE WORST CONDITION THEY HAVE SEEN THEM. THEY CONCERNED SINCE IT WAS TWO DIFFERENT UNITS AND BUILDINGS AND MOST LIKELY TWO DIFFERENT LOTS. THE PICTURE OF THE BELOW WAS PEEL BACK FROM THE PADS ON 9SE, BUT THEY DID NOT HAVE THE LOT NUMBER OF THESE PADS. OTHER PICTURES BELOW WERE THE PADS FROM THE JHN NEONATAL INTENSIVE CARE UNIT (NICU) BEING HELD TOGETHER, AND THE PACKAGING, LOT #NGHY5076.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY AWARE OF THE PAD ISSUE IN THE JHN NEUROSENSORY INTENSIVE CARE UNIT (NICU). THEY CAME UPON TWO MORE SETS WITH THE SAME ISSUE THIS WEEK ON 9SE. THESE PADS DID NOT STICK EITHER, PEELED BACK ON TO THEMSELVES ON SEVERAL PADS AND AS THE WATER TEMPERATURES FLUCTUATED, THE GEL CAME OFF THE PADS AND ON TO THE PATIENT, ALMOST IN A MELTING FASHION. THEY WERE NOT SURE IF THERE HAS BEEN A DIFFERENT MANUFACTURER OVER THE LAST FEW YEARS AND THE PADS HAVE BEEN GETTING WORSE AND WORSE THAT WAS MATERIAL COMING OFF AROUND THE HOSES AND THEN PADS NOT STICKING TO THE PATIENT, BUT THIS WAS THE WORST CONDITION THEY HAVE SEEN THEM. THEY CONCERNED SINCE IT WAS TWO DIFFERENT UNITS AND BUILDINGS AND MOST LIKELY TWO DIFFERENT LOTS. THE PICTURE OF THE BELOW WAS PEEL BACK FROM THE PADS ON 9SE, BUT THEY DID NOT HAVE THE LOT NUMBER OF THESE PADS. OTHER PICTURES BELOW WERE THE PADS FROM THE JHN NEUROSENSORY INTENSIVE CARE UNIT (NICU) BEING HELD TOGETHER, AND THE PACKAGING, LOT #NGHY5076. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 10MAY2024, BIOMED SPOKE TO ARCTIC SUN SUPPORT AND THERE WAS NO NEED TO SEND IN DEVICE. THE PADS WERE AFFECTED. THE PADS WERE REMOVED FROM PATIENT AND NEW PADS DELIVERED BY REPRESENTATIVE. BOTH PATIENTS AFFECTED, WENT THROUGH TWO SETS OF PADS AND THEY COMPLETED THERAPY ON THE SAME DEVICE BUT DIFFERENT PADS. PATIENT DID NOT ADEQUATELY COOL UNTIL THE PAD PROBLEM WAS DETECTED AND THE PADS WERE SWITCHED OUT. THERE WERE 4 SETS OF PADS WHICH ARE DEFECTIVE. THE PROBLEM OCCURRED THE ENTIRE COOLING CYCLE FOR ALL PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000727 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS ARCTIC GEL PADS DWJ MEDIVANCE, INC. ¿ 1725056 NGHY5076 10801741080088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other