BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 21559483 · Received March 10, 2025

    Report

    Report Number
    1018233-2025-01567
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    March 5, 2025
    Report Date
    April 30, 2025
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741127755
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE IDENTIFIED IS A WEAK CIRCULATION PUMP. THE DEVICE WAS EVALUATED UPON RECEIPT. PRIMED TO FILL. SERVICED CIRCULATION PUMP. CTU FLOW IS READING 500 ML/M LOW DUE TO AN IMPAIRED IMPELLER. THE CIRCULATION AND MIXING PUMP MOTORS ARE MAKING A CLACKING SOUND WHEN COLD STARTED. PERFORMED PM PROCEDURE. SERVICED MIXING PUMP. REPLACED HEATER, MANIFOLD O-RINGS, TANK TUBING, CIRCULATION PUMP MOTOR, MIXING PUMP MOTOR, FLOWMETER. THE ARCTIC SUN 5000 PASSED ALL PERFORMANCE TESTING, CALIBRATION AND ELECTRICAL SAFETY TESTS AND IS FUNCTIONING PROPERLY AND READY FOR USE. A DHR IS NOT REQUIRED AS THE REPORTED EVENT IS NOT AN OUT OF BOX FAILURE AND THEREFORE THE REPORTED EVENT IS NOT MANUFACTURING RELATED. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING 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 ARCTIC SUN DEVICE WOULD NOT FILL. NO SUCTION AT LEFT PORT, FAILED CIRCULATION PUMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WOULD NOT FILL. NO SUCTION AT LEFT PORT, FAILED CIRCULATION PUMP. PER SAMPLE EVALUATION RESULTS ON 15APR2025, CTU FLOW WAS READING 500 ML/M LOW DUE TO AN IMPAIRED IMPELLER. THE CIRCULATION PUMP MOTOR WAS MAKING A CLACKING SOUND WHEN COLD STARTED. THE MIXING PUMP MOTOR WAS MAKING A CLACKING SOUND WHEN COLD STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197259 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741127755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other