BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 12092956 · Received June 30, 2021

    Report

    Report Number
    1018233-2021-03924
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 7, 2021
    Report Date
    December 1, 2021
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE DEVICE WAS WORKING PROPERLY. IT WAS FOUND THAT THE PRODUCT MET SPECIFICATIONS. NO REPAIRS WERE MADE FOR THE REPORTED ISSUE. THE PUMP/SYSTEM HAD A HIGH RATE. THE CIRC/MIXING PUMP, HEATER AND BOTH DRAIN PORTS WERE REPLACED. THE ARCTIC SUN 5000 PASSED ALL PERFORMANCE TESTING, CALIBRATION, AND ELECTRICAL SAFETY TESTS. THE UNIT IS READY FOR USE. THE DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT WAS UNCONFIRMED. AS THE REPORTED ISSUE WAS UNCONFIRMED, THE LABELING REVIEW IS NOT REQUIRED. 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 ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ARCTIC SUN DEVICE HAD NO WATER CIRCULATION. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 04AUG2021, STATED THAT THIS FAILURE HAPPENED WHILE THE THERAPY. PATIENT SWITCHED TO A DIFFERENT DEVICE AND COMPLETED THERAPY ON SAME DEVICE. DEVICE WAS REPAIRED AT CRS MEDICAL AND ISSUE RESOLVED. PER SAMPLE EVALUATION, THE PUMP/SYSTEM HAD A HIGH RATE

    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 ARCTIC SUN DEVICE HAD NO WATER CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991060 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other