BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANOX METRA

    MDR report key: 20063683 · Received August 26, 2024

    Report

    Report Number
    3011560054-2024-00072
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 26, 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

    A SERVICE ENGINEER (SE) EVALUATED THE DEVICE AT THE CUSTOMER SITE. SE DISCOVERED FLUID INGRESS IN BOTH THE HAPTIC AND PORTAL PINCH VALVES. SE WAS UNABLE TO MANUALLY MOVE PINCH VALVES. SE DISASSEMBLED, CLEANED, REASSEMBLED, REINSTALLED BOTH VALVE BODIES. THE DEVICE PASSED FUNCTIONAL TESTING AFTERWARDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER PRIMING THE DEVICE WITH ALBUMIN AND PERFORMING THE LEAK TEST, THE PORTAL PINCH VALVE WAS NOT ENGAGING WHEN STOPPING PERFUSION DESPITE READING 100% ON THE GRAPHICAL USER INTERFACE SCREEN. THE DEVICE USERS CONTINUED THE REST OF PRIMING WITH PACKED RED BLOOD CELLS WHILE TROUBLESHOOTING WAS PERFORMED AND THE PINCH VALVE WAS CLEANED. THIS TROUBLESHOOTING WAS NOT SUCCESSFUL, THUS IT WAS RECOMMENDED THAT THEY DISCONTINUE USE OF THE DEVICE. SUBSEQUENTLY, THE DEVICE USER CONFIRMED THAT THE DONOR LIVER WAS SUCCESSFULLY TRANSPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270555 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