BEUDAMED
    FDA Adverse Event Other Summary report: N

    O2 INSTANT FLOW VALVE

    MDR report key: 2007742 · Received February 25, 2011

    Report

    Report Number
    2518436-2011-00001
    Event Type
    Other
    Date Received
    February 25, 2011
    Date of Event
    November 17, 2010
    Report Date
    February 24, 2011
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Product Code
    BTM
    PMA / PMN Number
    K970959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, INSTRUMENTATION INDUSTRIES INC. (III) WAS NOTIFIED BY (B)(6) OF (B)(6) HOSPITAL THAT OUR BE 3000-RA O2 INSTANT FLOW VALVE WAS IN USE WHEN A CRITICALLY-ILL PREMATURE INFANT WAS BEING MOVED FROM AN INFANT WARMER TO AN EXTRACORPOREAL MEMBRANE OXYGENATION BED FOR TRANSFER TO THE PEDIATRIC INTENSIVE CARE UNIT FOR ECMO THERAPY. TO PROVIDE BREATHING GAS TO THE PATIENT DURING THE MOVE, IT WAS NECESSARY TO DISCONNECT HER FROM HFOV AND USE MANUAL BAG VENTILATION. DURING THE MOVE, OXYGEN WAS ACCIDENTALLY CUT OFF TO THE PATIENT DUE TO SOMEONE PLACING A BLOOD PRESSURE CUFF ON THE INSTANT FLOW VALVE, WHICH CLOSED THE VALVE AND STOPPED THE FLOW OF GAS TO THE BAG. AS EXPLAINED TO III, THE PATIENT WENT INTO CARDIO-RESPIRATORY ARREST. SHE WAS PLACED BACK ON THE HFOV, WHERE SHE RESPONDED TO INTERVENTIONS. IT WAS THEN NOTICED THAT THE BLOOD PRESSURE CUFF WAS RESTING ON THE INSTANT FLOW VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O2 INSTANT FLOW VALVE VALVE, O2 INSTANT FLOW VALVE BTM INSTRUMENTATION INDUSTRIES, INC. BE 3000-RA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Life Threatening| R