BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORGANOX METRA

    MDR report key: 23556654 · Received November 14, 2025

    Report

    Report Number
    3011560054-2025-00131
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    October 7, 2025
    Report Date
    November 14, 2025
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    5060462240005
    PMA / PMN Number
    P200035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE DATA CONFIRMED NORMAL OPERATION DURING THE PERFUSION. NO DEVICE FAULT OR MALFUNCTION WAS IDENTIFIED. THE OBSERVED CLINICAL OUTCOME (PNF) WAS NOT RELATED TO DEVICE PERFORMANCE.

    Description of Event or Problem · 0

    FOLLOWING PERFUSION AND TRANSPLANT, THE DONOR LIVER DEVELOPED PRIMARY NON-FUNCTION (PNF). THE PATIENT UNDERWENT RE-TRANSPLANTATION AND WAS RECOVERING POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2806429 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 Required Intervention