BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANOX METRA

    MDR report key: 25322505 · Received May 28, 2026

    Report

    Report Number
    3011560054-2026-00117
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 28, 2026
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    5060462240005
    PMA / PMN Number
    P200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RECEIVED FOR SERVICING. DURING SERVICING, THE REPORTED EVENT COULD BE CONFIRMED WITH THE IFB RESETTING CONSTANTLY. BATTERY LEVELS WOULD DROP TO 5%, PINCH VALVES WOULD RESET, BLOOD PUMP WOULD STOP AND ALARMS WERE INTERMITTENTLY NOTED. UPON REMOVAL OF THE AIR PUMP AND DIVERTER VALVE ASSEMBLY, THE IFB BOARD OPERATED NORMALLY. ADDITIONAL TESTING WAS PERFORMED USING AN EXTERNAL POWER SUPPLY AND THE DIVERTER VALVE WAS FOUND TO NOT ACTUATE. FURTHER TESTING CONFIRMED GOOD OPERATION OF THE IFB BOARD. THE AIR PUMP AND DIVERTER VALVE WERE REPLACED, AND THE DEVICE SUBSEQUENTLY PASSED ALL APPLICABLE TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EIGHT HOURS INTO PERFUSION, MESSAGE CODE 180 (IFB RESET) WAS NOTED MULTIPLE TIMES. THE BATTERY WOULD SHOW 97% THEN DRAIN TO 5% FOLLOWED BY THE RESERVOIR EMPTYING. TROUBLESHOOTING WAS UNSUCCESSFUL AND THE LIVER WAS TAKEN OFF THE PUMP AND COLD FLUSHED. THE LIVER WAS SUCCESSFULLY TRANSPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243295 ORGANOX METRA NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR QQK ORGANOX LIMITED 5060462240005

    Patients

    Seq Age Sex Outcome Treatment
    1