BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAUTILUS SMART ECMO MODULE WITH BALANCE BIOSURFACE

    MDR report key: 11824590 · Received May 14, 2021

    Report

    Report Number
    3011468686-2021-00006
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 17, 2021
    Report Date
    May 12, 2021
    Manufacturer
    MC3 INC.
    Product Code
    BYS
    PMA / PMN Number
    K191935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS AT MANUFACTURER. THE DEVICE WAS TESTED WITH A PRESSURIZED WATER TEST (BLOOD PATH). THE DEVICE IS CURRENTLY ON TEST AND NO LEAK HAS BEEN OBSERVED AT THIS POINT (DEVICE HAS BEEN ON TEST FOR 2 DAYS).

    Description of Event or Problem · 1

    DURING AN OXYGENATOR SWAP FROM A COMPETITORS OXYGENATOR TO MC3, SN#(B)(4) WAS FOUND TO HAVE A LEAK. BLOOD WAS SEEN DRIPPING FROM THE GAS EXHAUST PORT ON THE BOTTOM OF THE DEVICE. THE OXYGENATOR WAS SWAPPED OUT FOR ANOTHER NAUTILUS AND NO PATIENT HARM WAS OBSERVED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723144 NAUTILUS SMART ECMO MODULE WITH BALANCE BIOSURFACE MC3 SMART ECMO OXYGENATOR BYS MC3 INC. 48135 2012169

    Patients

    Seq Age Sex Outcome Treatment
    1