BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANOX METRA

    MDR report key: 21349887 · Received February 10, 2025

    Report

    Report Number
    3011560054-2025-00013
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 15, 2025
    Report Date
    February 10, 2025
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    5060462240005
    PMA / PMN Number
    P200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED BY A SERVICE ENGINEER (SE). THE SE FOUND NO DEBRIS ON THE PORTAL PINCH VALVE DURING INSPECTION. REVIEW OF DEVICE DATA POINTED TO INTERMITTENT DROPOUTS ON THE INTERFACE BOARD (IFB) WITH MESSAGE CODE 180 (IFB TIMEOUT). THE SE REPLACED THE IFB, KEYPAD, AND KEYPAD 1 CABLE AS A PRECAUTIONARY MEASURE. SUBSEQUENTLY, THE DEVICE PASSED ALL TESTING.

    Description of Event or Problem · 0

    THE DEVICE USER (DU) REPORTED THAT THE METRA WAS ALERTED WITH MESSAGE CODE 370 (LOW PORTAL VEIN FLOW). UPON INSPECTION, THEY NOTED THAT THE PORTAL PINCH VALVE (PPV) WAS OCCLUDED AT 100% IN LIVER ON BOARD MODE WITH A FULL AND STABLE RESERVOIR. THE DU STATED THAT THERE WAS A FIVE MINUTE PERIOD OF NO PORTAL FLOW APPROXIMATELY 18 HOURS INTO THE PERFUSION. THE DU HAD COMPLETED TROUBLESHOOTING TO RESTORE PORTAL FLOW. SUBSEQUENTLY, THE PERFUSION PROCEEDED WITHOUT ISSUES AND THE LIVER WAS TRANSPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684447 ORGANOX METRA NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR QQK ORGANOX LIMITED 5060462240005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown