BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 22196590 · Received June 12, 2025

    Report

    Report Number
    1018233-2025-04517
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    April 7, 2025
    Report Date
    June 11, 2025
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080142
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE FAILED CALIBRATION WAS DETERMINED TO BE A FAILED CIRCULATION PUMP. THE DEVICE WAS EVALUATED UPON RECEIPT. DURING A CALIBRATION CHECK T3 WOULD NOT READ BELOW 30 DEGREES C DUE TO NO FLOW THROUGH THE MANIFOLD. CALIBRATION ERROR 80 RECEIVED. SERVICED THE CIRCULATION PUMP. MIXING PUMP MOUNT WAS FOUND TO BE FRACTURED. FLOWMETER WAS READING OVER 300 ML/M LOWER THAN THE CTU VALUE. A 2000-HOUR PM WAS COMPLETED ON THE DEVICE. REPLACED MIXING PUMP MOTOR. REPLACED FLOWMETER. AS PART OF THE PM, SERVICED MIXING PUMP, REPLACED HEATER, DRAIN VALVES, BOTH MANIFOLD O-RINGS, DOUBLE BEND TUBE, AND CHILLER EVAPORATOR OUTLET TUBE. REPLACED THE CONTROL PANEL COIN CELL DUE TO AGE. THE ARCTIC SUN 5000 PASSED ALL PERFORMANCE TESTING, CALIBRATION AND ELECTRICAL SAFETY TESTS AND IS FUNCTIONING PROPERLY AND READY FOR USE. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. A DHR REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS NOT AN OUT OF BOX FAILURE AND THEREFORE THE REPORTED EVENT IS NOT MANUFACTURING RELATED. 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 BIOMED STATED THAT THE ARCTIC SUN DEVICE WAS BEING CALIBRATED AND RECEIVED AN ERROR 82 (WATER CHECK TIME OUT - OTHER CONDITION). PER ADDITIONAL INFORMATION UPDATED FROM TTM ON 07APR2025, BIOMED STATED ON LAST STEP OF CALIBRATION THEY KEEP GETTING ERROR 82 (WATER CHECK TIME OUT - OTHER CONDITION). PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 06JUN2025, IT WAS REPORTED THAT THE MIXING PUMP MOUNT WAS FOUND TO BE FRACTURED. FLOWMETER WAS READING OVER 300 ML/M LOWER THAN THE CTU VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200707 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741080142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other