BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRACH CARE CLOSED SUCTION SYSTEM FOR ADULTS

    MDR report key: 1960462 · Received January 13, 2011

    Report

    Report Number
    8030647-2011-00001
    Event Type
    Death
    Date Received
    January 13, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED FOR (B)(4) WITH LOT NUMBER M0144T605. PRODUCTION RECORDS WERE REVIEWED AND THE PRODUCT MET MANUFACTURING SPECIFICATIONS AND WAS ACCEPTED IN THE QA INSPECTIONS. WE WERE UNABLE TO EVALUATE THE DEVICE AS IT WAS NOT RETURNED TO KIMBERLY-CLARK. DIRECTIONS FOR USE WARN:"CAP ON TRACH CARE T-PIECE PREVENTS CONTINUOUS FLOW THERAPY. REMOVE CAP BEFORE STARTING CONTINUOUS FLOW THERAPY. FAILURE TO REMOVE CAP PRIOR TO CONTINUOUS FLOW THERAPY MAY RESULT IN SERIOUS INJURY OR DEATH." INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. DEVICE NOT RETURNED TO KIMBERLY-CLARK BY USER FACILITY.

    Description of Event or Problem · 1

    KIMBERLY-CLARK OBTAINED A REPORT FROM THE MAUDE DATABASE STATING, "PT HAD FREQUENT NEED FOR SUCTIONING DUE TO COPIOUS SECRETIONS. RT ATTACHED CLOSED SUCTION SYSTEM WITH T-PIECE TO TRACH FOR EASE OF SUCTIONING AND PT COMFORT. PT ALSO HAD HIGH FLOW OXYGEN TO OTHER SIDE OF T-PIECE. AFTER SUCTION SYSTEM ATTACHED, PT EXPERIENCED RESPIRATORY DISTRESS. RESPIRATORY THERAPIST (RT) AT BEDSIDE WAS CALLED WITH REQUEST TO ATTEND TO AN EMERGENT PT IN (B)(6). RT SUPERVISOR CAME TO THIS PT'S ROOM TO ASSIST. UPON ARRIVAL TO THIS PT'S ROOM, RT SUPERVISOR NOTED PT IN SEVERE RESPIRATORY DISTRESS. SUPERVISOR NOTED AIR MOVEMENT AROUND TRACH AND SUSPECTED CUFF LEAK. RT INJECTED 2 CC AIR INTO TRACH CUFF IN EFFORT TO SECURE SEAL. RT NOTED LARGE AMOUNT OF SUBCUTANEOUS AIR. CLOSED SUCTION SYSTEM WITH T-PIECE REMOVED AND LARGE AMOUNT OF AIR EXHAUSTED FROM TRACH. SUSPECTED PNEUMOTHORAX. ATTEMPTED TO VENTILATE PT WITH BAG-VALVE. UNABLE TO MOVE AIR INTO TRACH. UNABLE TO FIND PULSE. NO CPR INITIATED AND DISCONTINUED EFFORTS TO VENTILATE BECAUSE PT WAS DNR. SUPERVISING RT REMOVED DIRTY EQUIPMENT FROM ROOM. WHILE TAKING DIRTY EQUIPMENT FOR DISPOSAL, RT NOTED SUCTION DEVICE STILL HAD THE END CAP IN PLACE ON T-PIECE. ALTERNATE END OF T-PIECE HAD HIGH FLOW OXYGEN. SUSPECTED PT UNABLE TO EXHALE ADEQUATELY. SUSPECTED PNEUMOTHORAX." KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS RECORD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACH CARE CLOSED SUCTION SYSTEM FOR ADULTS TRACH CARE CLOSED SUCTION BSY KIMBERLY-CLARK HEALTH CARE M0144T605

    Patients

    Seq Age Sex Outcome Treatment
    1 Death