BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORGANOX METRA

    MDR report key: 23556630 · Received November 14, 2025

    Report

    Report Number
    3011560054-2025-00130
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    October 15, 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 WERE REVIEWED AND CONFIRMED EXPECTED PERFORMANCE. NO DEVICE MALFUNCTION OR ABNORMAL BEHAVIOR WAS IDENTIFIED.

    Description of Event or Problem · 0

    FOLLOWING PERFUSION AND TRANSPLANT, THE DONOR LIVER DEVELOPED PRIMARY NON-FUNCTION (PNF) WITH ENZYMES REACHING 25,000 U/L. THE PATIENT UNDERWENT RE-TRANSPLANTATION AND RECOVERED POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2833075 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