BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY (#8 DIC)

    MDR report key: 271079 · Received March 23, 2000

    Report

    Report Number
    271079
    Event Type
    Death
    Date Received
    March 23, 2000
    Date of Event
    March 20, 2000
    Report Date
    March 23, 2000
    Manufacturer
    MALLINCKRODT INC.
    Product Code
    BTO
    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 OBSERVED AT 2:30AM, ASLEEP. WATER WAS EMPTIED FROM THE VENTILATOR TUBING, THE PT AWOKE BRIEFLY, THEN WENT BACK TO SLEEP. AT 3:25AM, NURSE PASSED PT'S ROOM, OBSERVED FACIAL PALLOR, WENT INTO ROOM AND OBSERVED THAT THE DISPOSABLE INNER CANNULA WAS PARTIALLY DISLODGED FROM THE TRACH TUBE. APPROX 1/2 INCH OF THE TIP OF THE INNER CANNULA REMAINED IN THE TRACH, VENTILATOR TUBING STILL ATTACHED TO THE INNER CANNULA, AND VENTILATING THE PT- CHEST NOTED TO RISE AND FALL. THE PT WAS FOUND TO BE WITHOUT A PULSE. THE PT WAS A QUADRIPLEGIC, C1, SECONDARY TO A MOTOR VEHICLE ACCIDENT, AND HAD RESPIRATORY FAILURE REQUIRING ARTIFICIAL VENTILATION (AEQUITRON LP10 VENT). PROBLEM: DISLODGEMENT OF DISPOSABLE INNER CANNULAS HAVE BEEN PREVIOUSLY NOTED. IT IS PROBLEMATIC FOR VENTILATED PTS, AS THE VENTILATOR MAY NOT SENSE THE DECREASE IN PRESSURE AND MAY NOT ALARM. THE FACILITY MEDICAL STAFF IS CURRENTLY WRITING A POLICY RESTRICTING OR ELIMINATING USE OF TRACHS WITH DISPOSABLE INNER CANNULAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY (#8 DIC) DISPOSABLE INNER CANNULA (TRACH) BTO MALLINCKRODT INC. CE 0050 M99133000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death