BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA

    MDR report key: 1916076 · Received December 6, 2010

    Report

    Report Number
    1916076
    Event Type
    Death
    Date Received
    December 6, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 19, 2010
    Product Code
    CAI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) BOY UNDERWENT A SUCCESSFUL MINOR ORTHOPEDIC SURGERY AND WAS BROUGHT TO THE RECOVERY ROOM STILL INTUBATED, BUT BREATHING ON HIS OWN. A BIFURCATED ANESTHESIA CIRCUIT USED WHILE THE PT IS ON THE VENTILATOR IN THE OPERATING ROOM WAS DETACHED FROM THE VENTILATOR AND USED AS AN OXYGEN DELIVERY SYSTEM FOR THE TRANSPORT TO THE RECOVERY ROOM. SUPPLEMENTAL OXYGEN WAS APPLIED IN TRANSIT FROM THE OPERATING ROOM TO RECOVERY. ONE END OF THE Y CIRCUIT WAS ATTACHED TO A PORTABLE O2 TANK, AND THE OTHER END WAS LEFT OPEN AND LYING ON THE BOY'S CHEST. UPON ARRIVAL TO THE RECOVERY ROOM, THE PORTION OF THE TUBING ON THE CHEST WAS ATTACHED TO O2 ON THE WALL. SHORTLY AFTER ARRIVAL, THE CHILD'S CONDITION DETERIORATED, AND IT WAS DISCOVERED THAT THE OXYGEN DELIVERY WAS BEING APPLIED TO BOTH ENDS CREATING A CLOSED CIRCUIT. NEITHER THE NURSE NOR THE ANESTHESIOLOGIST WAS AWARE THAT THE CHILD WAS GETTING O2 INTO BOTH SIDES OF THE CIRCUIT AND HAD NO OUTLET FOR EXPIRED AIR. THIS SITUATION CAUSED THE LUNGS TO FILL TO CAPACITY AND EVENTUALLY CAUSED DAMAGE TO THE LUNGS AND CARDIAC ARREST. DESPITE VIGOROUS ATTEMPTS TO RESUSCITATE THE CHILD BY MULTIPLE PEDIATRIC SPECIALISTS, THE EFFORTS WERE NOT SUCCESSFUL AND HE EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA BIFURCATED ANESTHESIA CIRCUIT CAI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death