BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN 5000

    MDR report key: 12080672 · Received June 28, 2021

    Report

    Report Number
    1018233-2021-03856
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 6, 2021
    Report Date
    July 29, 2021
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741127755
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED, BD HAS DETERMINED THAT THIS MDR EVENT IS NOT REPORTABLE. 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 PATIENT DID NOT REACH TARGET TEMPERATURE OF 91.4F USING ARCTIC SUN DEVICE. THE PATIENT TEMPERATURE WAS 94.5F AND WATER TEMPERATURE WAS 40F. THE FLOW RATE WAS MARGINAL (1.7LPM). DISCUSSED CAUSES OF HEAT GENERATION. THE PATIENT HAD KNOWN INFECTION AND WAS SHIVERING EARLIER. UPON DISCONNECTING AND RECONNECTING PADS THERE WAS FLOW UP TO 2.3LPM AND TREND WAS NEUTRAL. THE PATIENT WEIGHED 89KG. THE USER WAS NOT SURE OF PAD SIZE BUT CONFIRMS GOOD COVERAGE AND WAS ADVISED TO TREAT HEAT GENERATION PER PROTOCOL OR ORDERS. THE NURSE WAS ADVISED TO PERFORM DILIGENT SKIN CHECKS. PER FOLLOW UP 2 ON 08JUL2021 VIA NURSE, AFTER PAD CONNECTION THERAPY WAS COMPLETED WITH NO FURTHER ISSUES.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT REACH TARGET TEMPERATURE OF 91.4F USING ARCTIC SUN DEVICE. THE PATIENT TEMPERATURE WAS 94.5F AND WATER TEMPERATURE WAS 40F. THE FLOW RATE WAS MARGINAL (1.7LPM). DISCUSSED CAUSES OF HEAT GENERATION. THE PATIENT HAD KNOWN INFECTION AND WAS SHIVERING EARLIER. UPON DISCONNECTING AND RECONNECTING PADS THERE WAS FLOW UP TO 2.3LPM AND TREND WAS NEUTRAL. THE PATIENT WEIGHED 89KG. THE USER WAS NOT SURE OF PAD SIZE BUT CONFIRMS GOOD COVERAGE AND WAS ADVISED TO TREAT HEAT GENERATION PER PROTOCOL OR ORDERS. THE NURSE WAS ADVISED TO PERFORM DILIGENT SKIN CHECKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976770 ARCTIC SUN 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 50000000E NA 00801741127755

    Patients

    Seq Age Sex Outcome Treatment
    1 Other