BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCS HEART SYSTEM

    MDR report key: 22864349 · Received August 21, 2025

    Report

    Report Number
    3003152463-2025-00003
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    May 18, 2025
    Report Date
    August 21, 2025
    Manufacturer
    TRANSMEDICS INC
    Product Code
    QIK
    UDI-DI
    B00948225
    PMA / PMN Number
    P180051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRANSMEDICS ACKNOWLEDGES THE SUBMISSION OF MEDWATCH REPORT MW5171757 TO THE FDA BY THE OPO, WHICH REFERENCES THE SAME EVENT. UPON REVIEW OF THE REPORT, TRANSMEDICS HAS IDENTIFIED THE FOLLOWING INACCURACIES: 1. THE REPORT STATES THAT THE PATIENT INVOLVED WAS A 19-YEAR-OLD. THIS IS INCORRECT. THE INDIVIDUAL REFERENCED WAS THE ORGAN DONOR, NOT THE RECIPIENT. THERE WAS NO DIRECT PATIENT INVOLVEMENT. 2. THE EVENT DESCRIPTION CLAIMS THAT THE "TEMPERATURE PROBE WAS LEAKING." THIS IS INACCURATE. THE LEAK WAS IDENTIFIED IN THE BLOOD WARMER COMPONENT, NOT THE TEMPERATURE PROBE. 3. THE REPORT ASSERTS THAT THE UNITS ARE NOT TESTED PRIOR TO BEING BROUGHT OUT FOR USE. TRANSMEDICS WOULD LIKE TO CLARIFY THAT A LEAK TEST IS ALWAYS PERFORMED BEFORE THE PERFUSION MODULE IS SHIPPED FOR STERILIZATION. THE SUBMISSION OF MW5171757 PROMPTED TRANSMEDICS TO RE-REVIEW THE COMPLAINT ASSOCIATED WITH THIS INCIDENT. THIS EVENT IS BEING REPORTED TO THE FDA OUT OF AN ABUNDANCE OF CAUTION WHICH IS WHY IT HAS BEEN SUBMITTED PAST THE 30-DAY DUE DATE.

    Description of Event or Problem · 0

    DURING THE PRIMING OF A PERFUSION MODULE IN PREPARATION FOR A DCD HEART TRANSPLANT ON (B)(6) 2025, A RAPID AND SIGNIFICANT LEAK WAS OBSERVED ORIGINATING FROM THE BLOOD WARMER PREVENTING FLOW INTO THE AORTIC TUBING. AS A RESULT, THE PERFUSION MODULE COULD NOT BE USED, AND THE HEART COULD NOT BE PRESERVED ON THE OCS. THIS EVENT IS BEING REPORTED TO THE FDA OUT OF AN ABUNDANCE OF CAUTION. THE MALFUNCTION WAS IDENTIFIED PRIOR TO INSTRUMENTING THE ORGAN ON THE OCS SYSTEM. INVESTIGATION SUMMARY: THE RETURNED PERFUSION MODULE EXHIBITED A SIGNIFICANT LEAK AT THE JUNCTION BETWEEN THE PLASTIC AND ALUMINUM COMPONENTS OF THE BLOOD WARMER. LEAK TESTING CONFIRMED THE FAILURE, AND VISUAL INSPECTION REVEALED THAT THE INTERNAL O-RING WAS NOT FULLY SEATED IN ITS CHANNEL, CREATING A GAP THAT ALLOWED FLUID TO ESCAPE. THE ISSUE WAS DETERMINED TO BE AN ISOLATED ISSUE WHERE THE LEAK TEST DIDN'T IDENTIFY MANUFACTURING ERROR, WITH NO PRIOR OCCURRENCES IN OVER 10,000 OCS CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2410410 OCS HEART SYSTEM OCS HEART QIK TRANSMEDICS INC B00948225

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown