BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCS (TM) TRANSMEDICS PUMP

    MDR report key: 22309088 · Received June 23, 2025

    Report

    Report Number
    MW5171757
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    May 18, 2025
    Report Date
    June 17, 2025
    Manufacturer
    TRANSMEDICS, INC.
    Product Code
    QIK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE PRIMING PROCESS OF THE OCS TRANSMEDICS UNIT, THE TECHNICIAN OBSERVED THAT BLOOD WAS UNEXPECTEDLY POOLING AT THE BOTTOM OF THE MACHINE. UPON FURTHER INSPECTION, IT WAS DETERMINED THAT THE TEMPERATURE PROBE ON THE OCS MODULE WAS LEAKING, DESPITE NO VISIBLE CRACKS OR EXTERNAL DAMAGE. THE SPECIALIST PROMPTLY NOTIFIED THE RECOVERY SURGEON, DR. (B)(6), WHO CONFIRMED THE ISSUE AND TRIED TO TROUBLE SHOOT THE PROBLEM. UNFORTUNATELY, TRANSMEDICS DOES NOT HAVE ANY REDUNDANCIES BUILT INTO THEIR SYSTEM WHERE THEY MAY BRING ADDITIONAL CASSETTES, ETC. TO ADDRESS THESE TYPES OF FAILURES. THE TECHNICIAN ALSO INDICATED THAT NO CHECK IS PERFORMED PRIOR TO BRINGING UNIT ON SITE TO ENSURE IT IS WORKING PROPERLY. THIS RESULTED IN THE HEART OF A 19 YO DONOR HEART BEING DISCARDED. BOTH TRANSMEDICS AND THE TRANSPLANT CENTER, (B)(6) ARE AWARE OF THE FAILURE OF THIS UNIT AND THE OUTCOME OF THIS ORGAN RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671156 OCS (TM) TRANSMEDICS PUMP ORGAN CARE SYSTEM (OCS) HEART SYSTEM QIK TRANSMEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Other