BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCS HEART SYSTEM

    MDR report key: 20071022 · Received August 26, 2024

    Report

    Report Number
    3003152463-2024-00002
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    June 26, 2022
    Report Date
    August 26, 2024
    Manufacturer
    TRANSMEDICS INC
    Product Code
    QIK
    PMA / PMN Number
    P180051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS EVENT IS BEING REPORTED TO THE FDA AS A PART OF PROACTIVE QUALITY PLAN UNDERTAKEN BY TRANSMEDICS INC. THE REPORTABLE MALFUNCTIONS UNDER THIS QUALITY PLAN REPRESENT <0.2% OF ALL OCS TRANSPLANTS. DURING SETUP CUSTOMER REPORTED INABILITY TO CHANGE MAINTENANCE SOLUTION AOP TO AUTO MODE. TRANSMEDICS TECHNICAL SUPPORT TEAM DIAGNOSED THAT THE HEART PERFUSION MODULE (HPM) WASN'T MAKING GOOD CONTACT WITH THE CONSOLE. THE USER WAS INSTRUCTED TO DISCONNECT THE HPM TO CLEAN THE CONTACTS ON THE CONSOLE. IT WAS REPORTED THAT AT THE MOMENT OF DISCONNECTION, BLOOD LEAKED FROM HPM. DUE TO THE DONOR LOCATION IN HAWAII, THE ORGAN WAS TURNED DOWN SINCE THE LOCATION WAS TOO FAR AWAY FOR COLD STORAGE PRESERVATION. THE MODULE WAS NOT RETURNED TO TRANSMEDICS. THE ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED SINCE THE PHYSICAL DEVICE COULD NOT BE EXAMINED. THE RECEIVED PHOTOS SHOWED THE TUBE THAT GOES FROM THE BLOOD RESERVOIR TO THE PUMP HEAD WAS DISCONNECTED, WHICH LIKELY HAPPENED WHEN THE USER TRIED TO TAKE THE MODULE OUT WHILE IT WAS FULL OF BLOOD. THE POOR CONTACT BETWEEN THE MODULE AND CONSOLE MAY BE RELATED TO MAINTENANCE OF THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18314 OCS HEART SYSTEM OCS HEART SYSTEM QIK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown