BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORGANOX METRA

    MDR report key: 20212564 · Received September 13, 2024

    Report

    Report Number
    3011560054-2024-00082
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 13, 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

    EVENT DATA FROM THE DEVICE WAS RETRIEVED AND REVIEWED. EVIDENCE OF DOWNWARD TRENDING FLOWS WAS CONFIRMED. HOWEVER, ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED FROM THE DATA REVIEW. A SERVICE ENGINEER EVALUATED THE DEVICE AT THE CUSTOMER SITE. THE DEVICE WAS TESTED IN BOTH PREPARATION AND LIVER ON BOARD MODE. THE DEVICE CONSISTENTLY MAINTAINED AND REGULATED PRESSURES AND FLOW RATES AS EXPECTED. THE DEVICE PASSED ALL TESTING COMPLETED.

    Description of Event or Problem · 0

    THE DEVICE USER (DU) REPORTED ARTERIAL FLOW WAS LOW. INITIALLY ARTERIAL FLOW WAS GOOD (0.4L/MIN). BUT, IT TAPERED OFF AFTER A FEW MINUTES. AS A RESULT OF THE FLOW ISSUE, THE DU DECIDED TO DISCARD THE DONOR LIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638352 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