BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANOX METRA

    MDR report key: 23878672 · Received December 23, 2025

    Report

    Report Number
    3011560054-2025-00159
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 23, 2025
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    5060462240005
    PMA / PMN Number
    P200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS SERVICED ON SITE. REVIEW OF PERFUSION LOGS IDENTIFIED IFB BOARD RESETS CORRESPONDING TO THE REPORTED EVENTS; EACH RESET LASTED APPROXIMATELY 3 SECONDS, WITH RECOVERY OF FLOWS AND PRESSURES WITHIN 5 MINUTES. AS A PRECAUTION, THE IFB BOARD WAS REPLACED, AND THE DEVICE PASSED ALL APPLICABLE TESTING.

    Description of Event or Problem · 0

    DURING PERFUSION, THE DEVICE EXHIBITED INTERMITTENT POWER-CYCLING BEHAVIOR IN WHICH SOME COMPONENTS RESET AND DISPLAYED VALUES BRIEFLY WENT TO ZERO WHILE THE GUI REMAINED ACTIVE. THE DEVICE RECOVERED AFTER EACH OCCURRENCE, WHICH WAS NOTED THREE TIMES DURING THE PERFUSION. THE LIVER WAS SUCCESSFULLY TRANSPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057367 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