BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK AIRWAY EXCHANGE CATHETER

    MDR report key: 3003762 · Received March 8, 2013

    Report

    Report Number
    1820334-2013-00128
    Event Type
    Death
    Date Received
    March 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 15, 2013
    Manufacturer
    COOK, INC.
    Product Code
    KTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): (USE OF HIGH-PRESSURE OXYGEN). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A COOK AIRWAY EXCHANGE CATHETER WAS USED TO EXCHANGE AN UNCUFFED CRIC TUBE FOR A CUFFED CRIC TUBE. DURING THE EXCHANGE, SOMEONE HOOKED 24L OF OXYGEN FLOW (INSTEAD OF 2L) TO THE END OF THE CATHETER AS THERE WAS AN AIRWAY ADAPTER ON THE CAE. WITHIN 2 MINUTES THE PATIENT DEVELOPED BILATERAL PNEUMOTHORAXES, CARDIAC ARREST AND RUPTURED SCROTUM. HE EVENTUALLY PASSED AWAY. ALTHOUGH THE MISTAKE IN PUTTING 24L OF OXYGEN THROUGH THE CAE MAY HAVE DONE THE DAMAGE; THE PHYSICIAN FEELS THAT IF THE AIRWAY ADAPTER WASN'T AUTOMATICALLY ATTACHED, THE RT WOULDN'T HAVE AUTOMATICALLY ATTACHED O2. THE PATIENTS O2 SAT WAS FINE AND DIDN'T REQUIRE SUPPLEMENTAL OXYGEN. THE ADVERSE EVENTS WERE THE BILATERAL PNEUMOTHORAXES, CARDIAC ARREST AND RUPTURED SCROTUM DUE TO THE HIGH VOLUME OF AIR THAT PATIENT WAS RECEIVING THROUGH THE CAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99436 COOK AIRWAY EXCHANGE CATHETER KTI BRONCHOSCOPE ACCESSORY KTI COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death