BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANOX METRA

    MDR report key: 20161007 · Received September 6, 2024

    Report

    Report Number
    3011560054-2024-00076
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 6, 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

    FOLLOWING REVIEW OF THE COMPLAINT DETAILS, IT IS SUSPECTED THAT THE REPORTED EVENT WAS POSSIBLY DUE TO THE USER FAILING TO PROPERLY EJECT THE DISPOSABLE SET AT THE END OF THE PRIOR CASE, BUT THIS COULD NOT BE CONFIRMED DEFINITIVELY. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE WAS RESOLVED DURING TROUBLESHOOTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PORTAL PINCH VALVE (PPV) WAS 100 PERCENT CLOSED WHEN POWERING ON THE DEVICE, WHICH DID NOT ALLOW THE CUSTOMER TO PLACE THE DISPOSABLE SET ON THE DEVICE. THE CUSTOMER COMPLETED TROUBLESHOOTING TO RESOLVE THE ISSUE. AFTERWARDS, THE CUSTOMER WAS SUCCESSFULLY ABLE TO PLACE THE DISPOSABLE SET ONTO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226420 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