BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORGANOX METRA

    MDR report key: 20169757 · Received September 9, 2024

    Report

    Report Number
    3011560054-2024-00078
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 9, 2024
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    05060462240005
    PMA / PMN Number
    P200035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE ENGINEER (SE) EVALUATED THE DEVICE AT THE CUSTOMER SITE. THE SE WAS ABLE TO REPLICATE THE REPORTED MESSAGE CODE F050. THE TERUMO BLOOD GAS ANALYZER WAS REPLACED. SUBSEQUENTLY, THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    DEVICE USER (DU) REPORTED AN INABILITY TO CALIBRATE THE TERUMO SENSOR. MESSAGE CODE F050 (BAROMETRIC PRESSURE MEASUREMENT FAILURE) WAS DISPLAYED ON THE TERUMO SCREEN. THE DONOR LIVER WAS ALREADY CANNULATED AND PRIMED WITH ALBUMIN. TROUBLESHOOTING WAS PERFORMED IN AN EFFORT TO BYPASS MESSAGE CODE F050 BUT WAS UNSUCCESSFUL. RESTARTING THE DEVICE WITH AND WITHOUT THE CALIBRATOR CONNECTED DID NOT RESOLVE THE ISSUE AS MESSAGE CODE F050 DISPLAYED ON INITIATION OF STARTUP. THE SITE WANTED TO PERFUSE THE LIVER ON THE DEVICE BEFORE CONSIDERATION FOR TRANSPLANT. SINCE THEY WERE UNABLE TO DO SO, THE DONOR LIVER WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537472 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 Other