BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANOX METRA

    MDR report key: 25201431 · Received May 18, 2026

    Report

    Report Number
    MW5188304
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QBA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A LIVER WAS ON THE ORGANOX METRA PRESERVATION PUMP PREPARING IT FOR TRANSPLANT SURGERY, AND IT WAS DISCOVERED THAT A STOPCOCK WAS TURNED OFF TO THE MEDICATIONS FOR AN UNKNOWN AMOUNT OF TIME, BUT THE MACHINE DID NOT ALARM OR ALERT THE DEVICE USER THAT THE MEDICATIONS WERE NOT INFUSING. THE TUBING WAS LEAKING A SMALL AMOUNT OF FLUID WHEN THE STOPCOCK WAS TURNED OFF, AND THIS SCENARIO OF NO ALARMS/ALERTS AND LEAKING TUBING WAS RE-CREATED BY TURNING THE STOPCOCK OFF TO THE MEDICATIONS AND TAKING PICTURES AND VIDEOS (WHICH WERE SENT TO THE MANUFACTURER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298147 ORGANOX METRA NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR QBA ORGANOX LIMITED D0003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown