BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOVENT T HEAT AND MOISTURE EXCHANGER

    MDR report key: 245282 · Received October 20, 1999

    Report

    Report Number
    1217052-1999-00041
    Event Type
    Death
    Date Received
    October 20, 1999
    Date of Event
    September 10, 1997
    Report Date
    September 20, 1999
    Manufacturer
    SIMS PORTEX INC.
    Product Code
    BYD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE HOME CARE PT HAD A BIVONA PEDIATRIC TRACHEOSTOMY TUBE. A SIMS THERMOVENT T HEAT AND MOISTURE EXCHANGER WAS IN USE WITH THIS TUBE. ON SEPT. 10, THE PT'S AIRWAY BECAME BLOCKED WITH MUCUS AND SHE COULD NOT BREATHE. AN RN ALLEGEDLY TRIED TO REMOVE THE THERMOVENT T SO SHE COULD INSERT A CATHETER TO SUCTION OUT THE MUCUS PLUG, BUT WAS UNABLE TO REMOVE THE THERMOVENT T FROM THE THE TRACH TUBE. THE MOTHER AND SISTER ALLEGEDLY ALSO TRIED TO ASSIST IN REMOVING THE THERMOVENT T WITHOUT SUCCESS. THE PT BECAME FRIGHTENED AND ALLEGEDLY PULLED THE THERMOVENT T AND TRACHEOSTOMY TUBE OUT OF HER AIRWAY AND COLLAPSED DUE TO LACK OF OXYGEN. THE PT REPORTEDLY DIED BEFORE THE AMBULANCE ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOVENT T HEAT AND MOISTURE EXCHANGER CONDENSER, HEAT AND MOISTURE BYD SIMS PORTEX INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death BIVONA PEDIATRIC TRACHEOSTOMY TUBE (07/01/1997 TO| 09/10/1997).