BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEBULIZER TEE ADAPTER

    MDR report key: 1077554 · Received July 16, 2008

    Report

    Report Number
    MW5007668
    Event Type
    Death
    Date Received
    July 16, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 16, 2008
    Manufacturer
    SALTER LABS
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IS A MEDICALLY FRAGILE A MALE WHO SUSTAINED A TBI AT AGE 2 LEAVING HIM AN SPASTIC QUAD WITH A TRACH, G-TUBE, AND VP SHUNT AND TOTALLY DEPENDENT ON PROVIDERS FOR CARE. PT HAS A VERY LARGE NECK AND HEAD REQUIRING HIM TO HAVE A TRACH WITH AN EXTENSION SO THAT HIS NECK FOLDS DO NOT OCCLUDE HIS AIRWAY. TO PROVIDE HUMIDIFICATION, AN ADAPTER IS CONNECTED TO HIS TRACH. THE TRACH ADAPTER IS ATTACHED TO A TEE ADAPTER WHICH IS THEN ATTACHED TO MIST TUBING. THE TUBING IS ATTACHED TO A LARGE VOLUME NEBULIZER FILLED WITH DISTILLED WATER WHICH GENERATES A FINE MIST WITH MEDICAL AIR SET AT 5LPM. THE TEE ADAPTER HAS A THIRD OPENING WHICH ALLOWS EXPIRED CO2 AND SECRETIONS TO ESCAPE THE SYSTEM. IN 2008, PT WAS ATTACHED TO THIS SYSTEM WITHOUT THE TEE ADAPTER IN PLACE. THE MIST TUBING WAS ATTACHED DIRECTLY TO THE TRACH ADAPTER WITHOUT THE TEE ADAPTER THEREBY CREATING A SYSTEM WHERE EXPIRED CO2 MAY NOT SUFFICIENTLY BE EXPIRED. PT WAS FOUND EXPIRED WITH THE DESCRIBED SYSTEM FOR HUMIDIFICATION NOTED TO BE ATTACHED WITHOUT THE TEE ADAPTER. DOSE OR AMOUNT: APPLY MIST TO TRACH. FREQUENCY: QHS AND PRN. DATES OF USE: GREATER THAN 3 YEARS. DIAGNOSIS OR REASON FOR USE: HUMIDIFICATION FOR PT WITH TRACHEOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEBULIZER TEE ADAPTER TEE ADAPTER CAF SALTER LABS REF 8910 040508

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death THE MIST TUBING IS MFG BY KING SYSTEMS CORP.| LOT # Y07P1598| LOT # 1KTY2| CAT # 001820| MANUFACTURER IS PORTEX| 6 INCH SEGMENTED CORRUGATED HOSE 22MM.| ORDER| THE TEE ADAPTER IS CONNECTED TO A TRACH ADAPTER.| TRACH ADAPTER LABEL STATES MASK INTUBATION ADAPTER