BEUDAMED
    FDA Adverse Event Death Summary report: N

    MC3 NAUTILUS ECMO OXYGENATOR

    MDR report key: 19176886 · Received April 24, 2024

    Report

    Report Number
    3011468686-2024-00010
    Event Type
    Death
    Date Received
    April 24, 2024
    Date of Event
    March 8, 2024
    Report Date
    April 24, 2024
    Manufacturer
    MEDTRONIC DEXTER (MC3 INC.)
    Product Code
    BYS
    UDI-DI
    10854916006888
    PMA / PMN Number
    K191935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE TESTING CONFIRMED THERE WAS NO MALFUNCTION OF THE OXYGENATOR. IT WAS REPORTED THAT THE AIR ENTRY OCCURRED BEFORE THE OXYGENATOR AND THE OXYGENATOR DID NOT CONTRIBUTE TO THE PATIENT HARM. THERE WAS NO ALLEGED DEVICE MALFUNCTION. THE PROCEDURE CONTRIBUTED TO AIR ENTRY IN THE EXTRACORPOREAL CIRCUIT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A 9 MONTH OLD MALE PATIENT, WEIGHT 4 KG, WAS ON VA ECMO THERAPY THROUGH THE NECK. ON (B)(6) 2024 AT 3AM, IT WAS REPORTED THAT THERE WAS AIR IN THE VENOUS LINE. THE NAUTILUS OXYGENATOR WAS REPORTED AS HAVING VERY SMALL BUBBLES.. THE REPORTER INDICATED A BUBBLE DETECTOR DID NOT ALARM AND THE AIR WAS REMOVED FROM THE CIRCUIT. THE PATIENT WAS REPOSITIONED AND THE BUBBLES STOPPED FOR 10 MINUTES OR GREATER. THE OXYGENATOR WAS USED TO COMPLETE THE CASE. THE PATIENT WAS REPORTED AS DECEASED. DATE OF DEATH IS (B)(6) 2024, CAUSE OF DEATH UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156094 MC3 NAUTILUS ECMO OXYGENATOR NAUTILUS OXYGENATOR BYS MEDTRONIC DEXTER (MC3 INC.) 48145 2312235 10854916006888

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Male Death