BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEX TUBE

    MDR report key: 442016 · Received January 21, 2003

    Report

    Report Number
    442016
    Event Type
    Death
    Date Received
    January 21, 2003
    Date of Event
    January 9, 2003
    Report Date
    January 14, 2003
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    BZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS FOUND DEAD IN BED AT 0530. PT HAD BEEN USING A BI-PAP MACHINE CONNECTED WITH STANDARD CIRCUIT TUBING TO A CONCHA HUMIDIFIER IN THE MIDDLE OF THE CIRCUIT. A WATER TRAP WAS IN PLACE IN THE CIRCUIT AS WAS A BACTERIA FILTER, AN EXHALATION PORT, A TEMPERATURE PROBE AND A PROXIMAL PRESSURE LINE. THE CIRCUIT ENDED IN A FLEX TUBE WITH SWIVEL ADAPTER ATTACHED TO THE PT'S TRACHEOTOMY TUBE. THE CUFF ON THE TRACHEOTOMY TUBE WAS INFLATED. THE FLEX TUBE HAD BEEN TWISTED BETWEEN 180 DEGREES AND 360 DEGREES CAUSING IT TO COLLAPSE UPON ITSELF, OCCLUDING THE LUMEN. MEDICAL EXAMINER'S OFFICE HAS STATED THE PRELIMINARY CAUSE OF DEATH WAS ASPHYXIATION DUE TO THE TUBE'S OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX TUBE 8" FLEXIBLE CONNECTIVE TUBING BZO NELLCOR PURITAN BENNETT 6253 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death HEATER LIQUID OXYGEN TANK.| PURITAN BENNETT BIPAP S/T-D CONCHA HUMIDIFIER