BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMEDICS ORGAN CARE SYSTEM (OCS) LIVER

    MDR report key: 22863494 · Received August 21, 2025

    Report

    Report Number
    MW5175102
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 14, 2025
    Manufacturer
    TRANSMEDICS, INC.
    Product Code
    QIK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OPERATING ROOM SET FOR ORGAN RECOVERY ON (B)(6) 2025. DONOR'S LIVER WAS ACCEPTED FOR TRANSPLANT BY (B)(6) HOSPITAL, WITH PLANS FOR THE LIVER TO BE PLACED ON TRANSMEDICS OCS LIVER PUMP. AFTER THE LIVER WAS RECOVERED AT 21:04, IT WAS NOTED THAT THE TRANSMEDICS OCS LIVER PUMP WAS MALFUNCTIONING (OUR STAFF WERE TOLD BY THE TRANSPLANT TEAM THAT THE TRANSDUCER WAS TRACKED ON THE DISPOSABLE CARTRIDGE/TRAY). TRANSMEDICS WAS NOTIFIED, AND A NEW DEVICE HAD TO BE FLOWN IN, WHICH ARRIVED ON (B)(6) 2025 AT 02:41.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189748 TRANSMEDICS ORGAN CARE SYSTEM (OCS) LIVER ORGAN CARE SYSTEM (OCS) HEART SYSTEM QIK TRANSMEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other