BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANOX METRA

    MDR report key: 19935483 · Received August 7, 2024

    Report

    Report Number
    3011560054-2024-00069
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 7, 2024
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    05060462240005
    PMA / PMN Number
    P200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MESSAGE CODE 2330 (CRITICAL FAULT REPORTED) CAN RESULT FROM AN EMPTY RESERVOIR AND MESSAGE CODE 2170 (CRITICAL FAULT REPORTED) CAN RESULT FROM UNDETECTED BLOOD TEMPERATURE MEASUREMENTS. A SERVICE ENGINEER (SE) EVALUATED THE DEVICE AT THE CUSTOMER SITE. THE REPORTED RECIRCULATION PUMP ISSUE COULD NOT BE REPLICATED. A NEW ASCITES PUMP WAS INSTALLED AS A PRECAUTION. AFTERWARDS, FUNCTIONAL TESTING OF THE DEVICE RELATED TO THE REPORTED ISSUES WERE COMPLETED WITH NO ISSUES OBSERVED.

    Description of Event or Problem · 0

    DEVICE USER (DU) REPORTED THAT THE DEVICE RECIRCULATION PUMP STOPPED WORKING AND THE RESERVOIR WAS EMPTY. DU WAS IN A DIFFERENT ROOM WITH ANOTHER CASE. UPON RETURNING, THE DU OBSERVED MESSAGE CODES 330 (FREQUENTLY EMPTY BLOOD RESERVOIR), 2330 (CRITICAL FAULT REPORTED), AND 2170 (CRITICAL FAULT REPORTED) DISPLAYED ON THE SCREEN. THE RECIRCULATION PUMP WAS ON WHEN THE TROUBLESHOOTING CALL BEGAN. THE RESERVOIR WAS STABILIZED WITHIN MINUTES OF THE CALL. DU REPORTED NO VISIBLE SIGN OF BLEEDING IN THE BOWL. DATA WAS PLOTTED WHICH SHOWED ABOUT 20 MINUTES OF LOW RESERVOIR AND LIVER ON BOARD CYCLING. LABS WERE CHECKED AFTERWARDS AND NO CHANGE IN LACTATE WERE OBSERVED. THE DONOR LIVER WAS SUCCESSFULLY TRANSPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025893 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