BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY SINGLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY TUBE

    MDR report key: 366306 · Received October 31, 2001

    Report

    Report Number
    MW4003157
    Event Type
    Death
    Date Received
    October 31, 2001
    Report Date
    October 29, 2001
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE USE OF DEVICE, THE SHILEY SINGLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY TUBE, THE FOLLOWING OCCURRED: IV TUBING WAS INADVERTENTLY CONNECTED TO A SHILEY TRACHEOSTOMY TUBE PILOT LINE AND RESULTED IN OBSTRUCTION OF TUBING AND THE RESPIRATORY ARREST OF A PT. THE OBSTRUCTION WAS NOT NOTED UNTIL RESUSCITATION EFFORTS WERE INITIATED AND THE CODE TEAM WAS UNABLE TO INFLATE THE LUNG. THE TRACH PILOT LINE WAS CHECKED AND THE PT'S IV FLUID WAS DIRECTLY CONNECTED AND INFUSING VIA IMED PLUM PUMP INTO THE TRACHEOSTOMY TUBE CUFF. THE LINE WAS IMMEDIATELY DISCONNECTED AND APPROX 30 CC'S OF IV FLUID AND AIR WAS ASPIRATED VIA THE PILOT LINE ALLOWING VENTILATION TO ENSUE. THE PT SUFFERED AN ANOXIC BRAIN INJURY AND SUBSEQUENTLY DIED. THE CUFF DID REMAIN INTACT AND THERE WERE NO ISSUES WITH THE SHILEY DEVICE. PT SAFETY IS A MAJOR INITIATIVE OF THE HOSP AND IN KEEPING WITH PT SAFETY HOSP REQUESTS THAT MFR'S DEVICE BE REVIEWED; AND, STRONG CONSIDERATION BE GIVEN TO THE USE OF A PILOT PORT USING A STOPCOCK ALLOWING THE USER TO LOCK THE PILOT LINE DOWN ON THE TRACH. COLOR CODING THE PILOT TUBE IS ALSO STRONGLY RECOMMENDED. THESE RECOMMENDATIONS WOULD PROVIDE ADD'L SAFETY MECHANISMS TO THE PT AND HOPEFULLY KEEP A DEVASTATING EVENT SUCH AS OCCURRED TO THIS PT FROM HAPPENING TO ANYONE ELSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49315 SHILEY SINGLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH MALLINCKRODT MEDICAL TPI, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death