BEUDAMED
    FDA Adverse Event Summary report: N

    NEO-VERSO

    MDR report key: 1710461 · Received May 21, 2010

    Report

    Report Number
    1710461
    Date Received
    May 21, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 21, 2010
    Manufacturer
    CAREFUSION 211, INC.
    Product Code
    BZA
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    NURSE CALLED TO INFANT'S BEDSIDE BECAUSE HE HAD BEEN DESATURATING. PT. CURRENTLY BEING HAND BAGGED. WHEN WE TRIED TO REATTACH INFANT TO VENTILATOR PT STARTED TO DESATURATE AGAIN. TRIED TO SUCTION PT AT THIS TIME BUT UNABLE TO PASS IN-LINE SUCTION CATHETER THROUGH AIRWAY ACCESS ADAPTER. TRACH TUBE APPEARED TO BE OBSTRUCTED. THE INFANT RETURNED TO BASELINE AFTER A NEW TRACH TUBE WAS PLACED.======================HEALTH PROFESSIONAL'S IMPRESSION======================THE AIRWAY ACCESS ADAPTER IS REALLY A Y-CONNECTOR THAT ALLOWS STAFF TO SUCTION THE AIRWAY WITHOUT DISCONNECTING THE VENTILATOR. APPARENTLY A SILICONE SEAL CAME OFF THE ADAPTER AND LODGED IN THE CONE-SHAPED INPUT OF THE TRACH TUBE CAUSING THE OBSTRUCTION.======================MANUFACTURER RESPONSE FOR AIRWAY ACCESS ADAPTER, AIRLIFE======================NO OFFICIAL COMMENT YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEO-VERSO CONNECTOR, AIRWAY ACCESS BZA CAREFUSION 211, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO