BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAUTILUS ECMO OXYGENATOR

    MDR report key: 11754557 · Received April 30, 2021

    Report

    Report Number
    3011468686-2021-00005
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 30, 2021
    Manufacturer
    MC3 INC.
    Product Code
    BYS
    PMA / PMN Number
    K191935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS AT MANUFACTURER. THE DEVICE WAS TESTED AND THE LEAK WAS NOT CONFIRMED WITH A WATER TEST FOR THE BLOOD PATH. THE FIBER BUNDLE WAS EXAMINED AND THERE WAS EVIDENCE OF DRIED BLOOD ON THE DEVICE. THE DEVICE WAS FURTHER CLEANED WITH HYDROGEN PERIOXIDE WHICH REMOVED THE DRIED BLOOD. AFTER MORE THAN A DAY EXPOSED TO PEROXIDE-WATER, THE FIBER LEAK WAS CONFIRMED. DEVICES ARE 100% TESTED DURING THE MANUFACTURING FOR THIS TYPE OF LEAK WITHIN A SINGLE FIBER STRAND. IT IS INCONCLUSIVE AS TO WHY THE FIBER LEAK WAS NOT DETECTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    OXYGENATOR STARTED LEAKING BLOOD FROM THE GAS OUTLET PORT. THIS LEAK WAS NOTICED BY THE USER ONE HOUR AFTER STARTING ECMO THERAPY. THE DEVICE WAS EXCHANGED WITH ANOTHER OXYGENATOR. THERE WAS NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654388 NAUTILUS ECMO OXYGENATOR ECMO OXYGENATOR BYS MC3 INC. 48145 2008201

    Patients

    Seq Age Sex Outcome Treatment
    1