BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK AIRWAY EXCHANGE CATHETER WITH RAPI-FIT ADAPTER

    MDR report key: 1920942 · Received December 7, 2010

    Report

    Report Number
    MW5018524
    Event Type
    Death
    Date Received
    December 7, 2010
    Date of Event
    September 23, 2010
    Report Date
    December 7, 2010
    Manufacturer
    COOK MEDICAL INC.
    Product Code
    LRC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN 8 FR COOK AIRWAY EXCHANGE CATHETER - G07833 - C-CAE-8.0-45 USING RAPI-FIT ADAPTER CONNECTED TO WALL SOURCE OF OXYGEN AT 1 LITER/MIN GAS FLOW INTRODUCED DOWN 3.0 MM ID ENDOTRACHEAL TUBE TO FACILITATE CHANGE FOR LARGER ENDOTRACHEAL TUBE -3.5- IN 1000 GM INFANT WITH VENTILATOR DEPENDENCE AND LARGE AIR LEAK. DURING ENDOTRACHEAL TUBE EXCHANGE, AT THE POINT WHEN THE CATHETER WAS INTRODUCED INTO THE 3.0 ENDOTRACHEAL TUBE AND ADVANCED IN THE ENDOTRACHEAL TUBE, THE PT SUDDENLY DECOMPENSATED INTO CARDIOPULMONARY ARREST. DESPITE IMMEDIATE RESUSCITATION EFFORTS INCLUDING REINTUBATION, MEDICATIONS, ASPIRATIONS OF BOTH CHEST CAVITIES, AND VIGOROUS CPR ATTEMPTS FOR 30 MINUTES, SPONTANEOUS CIRCULATION DID NOT RETURN. THE PT WAS PRONOUNCED DECEASED AFTER THE RESUSCITATION TEAM DEEMED FURTHER ATTEMPTS FUTILE. DIAGNOSIS OR REASON FOR USE: LARGE ENDOTRACHEAL TUBE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK AIRWAY EXCHANGE CATHETER WITH RAPI-FIT ADAPTER AIRWAY EXCHANGE CATHETER LRC COOK MEDICAL INC. G07833 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Congenital Anomaly| D| S