BEUDAMED
    FDA Adverse Event Injury Summary report: N

    02 INSTANT FLOW VALVE

    MDR report key: 1998823 · Received February 10, 2011

    Report

    Report Number
    1998823
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    November 17, 2010
    Report Date
    February 10, 2011
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRITICALLY ILL PREMATURE INFANT WAS ON MAXIMUM THERAPY, INCLUDING MULTIPLE VASOCONSTRICTORS, HIGH FREQUENCY OSCILLATORY VENTILATION (HFOV) AT HIGH PRESSURE, 100% (FRACTION OF INSPIRED OXYGEN) FIO2, 20 PPM INHALED NITRIC OXIDE (INO), AND BILATERAL CHEST TUBES. THE INFANT WAS MOVED FROM AN INFANT WARMER TO AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) BED FOR TRANSFER TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU) FOR ECMO THERAPY. TO PROVIDE FLOW OF 100% OXYGEN AND INO TO THE BABY DURING THE MOVE, IT WAS NECESSARY TO DISCONNECT THE PATIENT FROM HFOV AND USE MANUAL BAG VENTILATION. THE BABY DECOMPENSATED DURING THE MOVE AND CARDIORESPIRATORY ARREST ENSUED. SHE UNDERWENT AGGRESSIVE RESUSCITATION, BUT DID NOT RESPOND TO INTERVENTIONS UNTIL SHE WAS PLACED BACK ON THE HFOV. IT WAS THEN NOTED THAT THE BLOOD PRESSURE CUFF HAD BEEN PLACED ON THE INSTANT FLOW VALVE, CLOSING THE VALVE AND STOPPING FLOW OF OXYGEN AND NITRIC OXIDE TO THE BAG.PHOTOGRAPHS ARE AVAILABLE UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 02 INSTANT FLOW VALVE VALVE, O2 INSTANT FLOW WITH FORKED ARM BTM INSTRUMENTATION INDUSTRIES, INC BE 3000-RA *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY Required Intervention