BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 22742891 · Received August 7, 2025

    Report

    Report Number
    1018233-2025-06584
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    April 15, 2025
    Report Date
    August 7, 2025
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080142
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. AT THIS TIME, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE ARCTIC SUN 5000 WAS EVALUATED UPON RECEIPT. DURING SERVICING IT WAS FOUND THAT ONE PUMP HEAD ALIGNMENT STUD WAS FOUND BREAKING OFF. NO ERROR CODES OBSERVED. CIRCULATION PUMP WAS SERVICED; PUMP MOTOR WAS REPLACED. FLOW METER WAS UNABLE TO OBTAIN READING ABOVE 1400 ML/M. DEVICE UNDERWENT 2000-HR PM PROCEDURE. FLOW METER WAS REPLACED. MIXING PUMP WAS SERVICED. HEATER, MANIFOLD O-RINGS, BOTH DRAIN VALVES, DOUBLE BEND TUBE, AND CHILLER EVAPORATOR OUTLET TUBE WERE REPLACED. THE ARCTIC SUN 5000 PASSED ALL PERFORMANCE TESTING, CALIBRATION AND ELECTRICAL SAFETY TESTS AND IS FUNCTIONING PROPERLY AND READY FOR USE. THE FLUID DELIVERY LINE WAS LEAK TESTED PER PROCEDURE AND PASSED ALL TESTS. 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. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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 CIRCULATION PUMP HEAD ALIGNMENT STUD BROKE OFF DURING SERVICING AND THE FLOWMETER UNABLE TO OBTAIN A FLOW READING ABOVE 1400 ML/M IN AN ARCTIC SUN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411009 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741080142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other