BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORGANOX METRA

    MDR report key: 24584372 · Received March 12, 2026

    Report

    Report Number
    3011560054-2026-00060
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    November 20, 2025
    Report Date
    April 17, 2026
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    5060462240005
    PMA / PMN Number
    P200035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE ENGINEER EVALUATED THE DEVICE AT THE CUSTOMER SITE AND THE DEVICE PASSED ALL TESTING. ADDITIONALLY, DEVICE DATA WAS REVIEWED. IT WAS NOTED THAT REPEATED 390 (LOW HEPATIC ARTERY FLOW) MESSAGES WERE SEEN THROUGHOUT THE PERFUSION. BUT, NO DEVICE MALFUNCTION WAS OBSERVED. AN INDEPENDENT MEDICAL EXPERT CONCLUDED THAT ROOT CAUSE OF THE LOW FLOW CODE WAS MOST LIKELY DUE TO AN ISSUE WITH ARTERIAL RECONSTRUCTION AND CANNULA POSITIONING. HOWEVER, THIS COULD NOT BE CONCLUDED DEFINITIVELY DUE TO THE INFORMATION AVAILABLE. B5 UPDATED TO INCLUDE ADDITIONAL EVENT DETAILS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS CURRENTLY PENDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LIVER WAS TRANSPLANTED ON (B)(6) 2025. THE POSTOPERATIVE COURSE WAS COMPLICATED BY ELEVATED LIVER FUNCTION TESTS AND THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2025 FOR EXPLORATORY LAPAROTOMY. NO CAUSE FOR THE WORSENING LIVER FUNCTION WAS IDENTIFIED. THE LIVER WAS DETERMINED TO HAVE PRIMARY NONFUNCTION (PNF) AND LIVER NECROSIS. THE PATIENT UNDERWENT RETRANSPLANTATION ON (B)(6) 2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CUSTOMER HAD POOR OUTCOME WITH THE CASE. THE LIVER WAS TRANSPLANTED. SUBSEQUENTLY, IT WAS REPORTED THAT THERE WAS PRIMARY NONFUNCTION AND LIVER NECROSIS. THEREFORE, THE LIVER WAS RETRANSPLANTED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301880 ORGANOX METRA NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR QQK ORGANOX LIMITED 5060462240005

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention| L