BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANOX METRA

    MDR report key: 19716911 · Received July 10, 2024

    Report

    Report Number
    3011560054-2024-00064
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 15, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    05060462240005
    PMA / PMN Number
    P200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SERVICE ENGINEER (SE) EVALUATED THE DEVICE AT THE CUSTOMER SITE. THE REPORTED ISSUE COULD NOT BE REPLICATED. NO ISSUES WITH THE OXYGEN DELIVERY SYSTEM WERE OBSERVED. DEVICE PASSED FUNCTIONAL TESTING.

    Description of Event or Problem · 0

    THE DEVICE USER (DU) REPORTED ERROR 410 WAS OBSERVED AT THE START OF PERFUSION. TROUBLESHOOTING WAS COMPLETED. THE GAS CONNECTOR CONNECTION WAS QUERIED. WHEN IT WAS RECONNECTED THE PO2 IMPROVED TO EXPECTED RANGE BUT O2% REMAINED HIGH. TWO AND ONE HALF HOURS LATER ERROR 410 RETURNED AND TROUBLESHOOTING WAS REPEATED WITH VERY SLOW IMPROVEMENT IN PO2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384758 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