BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANOX METRA

    MDR report key: 19931872 · Received August 7, 2024

    Report

    Report Number
    3011560054-2024-00068
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 7, 2024
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    05060462240005
    PMA / PMN Number
    P200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. A SERVICE ENGINEER EVALUATED THE DEVICE AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE, BUT DECIDED TO REPLACE THE POWER SUPPLY UNIT AS A PRECAUTION. AFTERWARDS, FUNCTIONAL TESTING WAS COMPLETED AND THE DEVICE PASSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS PLUGGED IN AND THE MASTER POWER SWITCH WAS ON WITH THE POWER ICON DISPLAYING ON THE GRAPHICAL USER INTERFACE SCREEN. BUT, AFTER ABOUT 30 MINUTES THE BATTERY PERCENTAGE DROPPED FROM 84% TO 83% AND THEN 82%. THE DEVICE WAS SWITCHED TO ANOTHER OUTLET. ADDITIONAL TROUBLESHOOTING WAS COMPLETED, BUT THE ISSUE WAS NOT RESOLVED. BOTH OUTLETS WORKED FOR OTHER EQUIPMENT. THE DEVICE WAS MOVED TO A THIRD OUTLET AND THEN STARTED TO CHARGE. THE DEVICE WAS RELOCATED TO ANOTHER ROOM WHERE IT BEGAN LOSING POWER AGAIN AT RATE ABOUT 1% EVERY 10-15MIN. EVENTUALLY, THE DEVICE USER WAS ABLE TO STABILIZE THE DEVICE AND MAINTAIN BATTERY POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220679 ORGANOX METRA NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR QQK ORGANOX LIMITED 05060462240005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown