BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 6731239 · Received July 20, 2017

    Report

    Report Number
    6731239
    Event Type
    Death
    Date Received
    July 20, 2017
    Date of Event
    June 23, 2017
    Report Date
    July 11, 2017
    Manufacturer
    CAREFUSION/BECTON, DICKINSON AND COMPANY
    Product Code
    CAH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) F TAKEN TO OPERATING ROOM FOR PLACEMENT OF A TRACH AND PEG. SHE WAS PLACED ON MECHANICAL VENTILATION, BUT THERE WAS NO RETURN OF END TIDAL CO2, SO VENTILATION COULD NOT BE CONFIRMED, THEREFORE, ANESTHESIA RE-INTUBATED THE PATIENT. CPR WAS THEN INITIATED DUE TO LOSS OF PULSE. UNFORTUNATELY, THE PATIENT WAS UNABLE TO BE REVIVED. UPON INSPECTION OF THE VENTILATOR, AN IV CAP WAS FOUND IN THE ELBOW PIECE OF THE TUBING, OCCLUDING IT. BOTH THE IV CAP AND TUBING ARE FROM THE SAME MANUFACTURER. THE INSIDE OF THE TUBING NARROWS AND THE IV CAP FITS PERFECTLY INSIDE. THE INVESTIGATION INTO HOW THIS HAPPENED IS ONGOING, HOWEVER, IT IS BELIEVED THAT THE IV CAP INADVERTENTLY ENDED UP IN THE TUBING AND WAS SUCKED INTO PLACE WHEN THE TEAM ATTEMPTED TO ADMINISTER POSITIVE PRESSURE VENTILATION. MTG DATE: 12/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508283 CAREFUSION IV CAP, BREATHING CIRCUIT ACC- ELBOW CAH CAREFUSION/BECTON, DICKINSON AND COMPANY 0001033472

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death