BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FABIUS TIRO

    MDR report key: 4080811 · Received September 5, 2014

    Report

    Report Number
    MW5038115
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    July 24, 2014
    Report Date
    September 5, 2014
    Manufacturer
    DRAGER
    Product Code
    BSZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS GIVEN A GENERAL ANESTHETIC FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE ANESTHESIA MACHINE WAS A DRAGER FABIUS TIRO EQUIPPED WITH A ONE VAPORIZER ARRANGEMENT BUT A RACK TO HOLD A SECOND EXCHANGEABLE VAPORIZER ( TO USE EITHER DESFLURANE OR SEVOFLURANE). THIS WAS A NEW, SECOND FABIUS TIRO ANESTHESIA MACHINE FOR THE DEPT; THE ORIGINAL MACHINE DID NOT HAVE THE HOLDING RACK FOR THE SECOND VAPORIZER. THE SECOND VAPORIZER IN THE NON-FUNCTIONAL POSITION WAS IN CLOSE PROXIMITY TO THE FUNCTIONAL ONE, AND THE DIALS ON EITHER VAPORIZER COULD BE TURNED AND ADJUSTED (I.E., NO LOCKING MECHANISM OR OTHER WARNING TO PREVENT TURNING ON THE NON-FUNCTIONAL VAPORIZER). THE ANESTHESIA PROVIDER WAS UNAWARE THAT THE SECOND VAPORIZER WAS NOT FUNCTIONAL IN IT'S POSITION, AND THINKING HE COULD USE EITHER VAPORIZER, CHOSE THE NON-FUNCTIONAL ONE. IN THE RECOVERY ROOM THE PT DESCRIBED BEING AWAKE BUT UNABLE TO MOVE DURING THE ERCP PROCEDURE. IN RETROSPECT, BETTER REDUCTION COULD HAVE BEEN DONE REGARDING THE NEW ANESTHESIA MACHINE FEATURES INCLUDING THE RAIL HOLDING THE SPARE VAPORIZER AND THE FACT THAT IT WAS NON-FUNCTIONAL. THE ANESTHESIA PROVIDER DID HAVE AN AGENT ANALYZER, BUT FAILED TO NOTE THE ABSENCE OF AGENT. THE VENDOR (DRAGER) WAS CONTACTED TO INQUIRE ABOUT ANY LOCKING MECHANISM OR SPECIAL LABELING THEY PROVIDE TO PREVENT INADVERTENT USE OF THE NON-FUNCTIONAL VAPORIZER - THEY HAVE NOTHING. WE HAVE EDUCATED ALL THE ANESTHESIA PROVIDERS AND HAVE REMOVED THE SPARE VAPORIZER FROM THE MACHINE UNTIL WE DEVICE A SAFETY MECHANISM THAT EITHER PREVENTS TURNING THE DIAL ON THE NON-FUNCTIONAL VAPORIZER, OR CLEARLY LABELS IT AS NON-FUNCTIONAL. WE BELIEVE THIS IS A PT SAFETY ISSUE AND DESIGN FLAW THAT NEEDS TO BE CORRECTED BY THE MANUFACTURER. IN CONTRAST TO THE HISTORICAL DESIGN ADVANCES IN THE SAFETY OF ANESTHESIA MACHINES OVER THE YEARS, THE LAYOUT ON THIS ANESTHESIA MACHINE IS LACKING SAFETY FEATURES (LOCKING MECHANISM OR CLEAR LABELING) THAT WOULD PREVENT A PROVIDER FROM THINKING HE HAD TURNED ON AN ACTIVE ANESTHESIA VAPORIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543278 FABIUS TIRO ANESTHESIA MACHINE BSZ DRAGER FABIUS TIRO

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other