BEUDAMED
    FDA Adverse Event Death Summary report: N

    MC3 NAUTILUS ECMO OXYGENATOR

    MDR report key: 19591077 · Received June 22, 2024

    Report

    Report Number
    3011468686-2024-00016
    Event Type
    Death
    Date Received
    June 22, 2024
    Date of Event
    April 25, 2024
    Report Date
    June 22, 2024
    Manufacturer
    MEDTRONIC DEXTER (MC3 INC.)
    Product Code
    BYS
    UDI-DI
    10854916006888
    PMA / PMN Number
    K191935
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED BY THE HOSPITAL.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE ECMO OXYGENATOR, IT WAS REPORTED THAT THERE WAS BLOOD LEAKING FROM THE GAS EXHAUST PORT. THE DEVICE LEAK DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT OUTCOME. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT EXPIRED, BUT THE OUTCOME WAS NOT RELATED TO THE OXYGENATOR. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CIRCUIT WAS PRIMED THE SAME DAY IT WAS USED, ROUGHLY 1-2 HOURS PRIOR TO USE ON THE PATIENT. THE CIRCUIT WAS PRIMED WITH NORMOSOL. THE PATIENT WAS A FAILURE TO WEAN FROM BYPASS AND WAS COMPLETELY HEPARINIZED PRIOR TO INITIATING ECMO. IT WAS ROUGHLY AN HOUR UNTIL THE LEAK WAS OBSERVED. PATIENT WAS TOO UNSTABLE TO CHANGE IT OUT. PHYSICIANS WERE NOTIFIED AND WERE IN AGREEMENT NOT TO CHANGE. THE DEVICE ISSUE DID NOT FACTOR INTO THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280744 MC3 NAUTILUS ECMO OXYGENATOR NAUTILUS OXYGENATOR BYS MEDTRONIC DEXTER (MC3 INC.) 48145 2403114 10854916006888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death