BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 19267864 · Received May 8, 2024

    Report

    Report Number
    1018233-2024-02616
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 6, 2024
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741127755
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS A FAILED FLOW METER. FLOW METER WAS READING 300 ML/M LOW CAUSING CALIBRATION FLOW ERRORS. REPLACED FLOW METER. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. 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 ARCTIC SUN DEVICE COULD NOT FILL. THE DEVICE WAS FULLY DRAINED WHEN ATTEMPTED TO FILL NO SUCTION AT LEFT PORT. FAILED CIRCULATION PUMP. THEY REQUESTED A QUOTE FOR 2000 HOUR SERVICE. IN EVALUATION RESULTS, IT WAS REPORTED THAT FAILED CIRCULATION PUMP MOTOR BEARING (PHOTO SAMPLES ATTACHED IN WO). FLOWMETER WAS REPLACED DUE TO READING 300 ML/M LOW CAUSING CALIBRATION FLOW ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100804 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741127755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other