BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAUTILUS ECMO OXYGENATOR WITH BALANCE BIOSURFACE

    MDR report key: 11939325 · Received June 4, 2021

    Report

    Report Number
    3011468686-2021-00007
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 3, 2021
    Manufacturer
    MC3 INC.
    Product Code
    BYS
    PMA / PMN Number
    K191935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PRODUCTION RECORDS FOUND THAT THE DEVICE PASSED ALL MANUFACTURING INSPECTIONS. THE DEVICE WAS RETURNED FOR ANALYSIS AT MANUFACTURER. VISUAL EXAMINATION SHOWED EVIDENCE OF BLOOD LEAK ON THE MANIFOLD CAPS. NO OTHER VISIBLE DEFECTS NOTED. THE DEVICE IS CURRENTLY ON TEST WITH PRESSURIZED HYDROGEN PEROXIDE AND NO LEAK HAS BEEN OBSERVED (DEVICE HAS BEEN ON TEST FOR 1 DAY) AT THIS POINT.

    Description of Event or Problem · 1

    DURING THE ECMO PROCEDURE, AFTER 5 MINUTES, DRIPPING FROM THE GAS OUTLET BEGAN. INLET PRESSURE = 207 MMHG, OUTLET PRESSURE = 195 MMHG, FLOW 4.3 L/MIN, NORMOTHERMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837756 NAUTILUS ECMO OXYGENATOR WITH BALANCE BIOSURFACE NAUTILUS OXYGENATOR BYS MC3 INC. 48145E 2009126

    Patients

    Seq Age Sex Outcome Treatment
    1