BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANESTHESIA DELIVERY UNIT

    MDR report key: 2864205 · Received December 6, 2012

    Report

    Report Number
    9610105-2012-00044
    Event Type
    Death
    Date Received
    December 6, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 13, 2012
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    BSZ
    PMA / PMN Number
    K050676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANESTHESIA DELIVERY UNIT (ADU) DOES NOT IDENTIFY GASES FLOWING IN ITS GAS CHANNELS. AS STATED IN THE ADU USER REFERENCE MANUAL (URM), "THE ADU O2 % IS A CALCULATED VALUE OF MEASURED FLOW DATA AND NOT A VALUE MEASURED BY AN OXYGEN ANALYZER. IN A CASE OF A HOSPITAL PIPELINE CROSS CONNECTION, ERRONEOUS VALUES WILL BE DISPLAYED." THE ADU IS EQUIPPED WITH A PROPORTIONAL REGULATOR, WHICH PREVENTS THE OPERATOR FROM ADMINISTERING AN OXYGEN (O2) / NITROUS OXIDE (N2O) / AIR MIXTURE CONTAINING LESS THAN 25% O2 IN FRESH GAS FLOW. OPERATION OF THIS HYPOXIC MIXTURE GUARD IS BASED ON MEASURED GAS FLOW ON THE ADU GAS CHANNELS. THE ADU WILL ALARM WITH "HYPOXIC MIXTURE" ALARM WHEN CALCULATED O2 CONCENTRATION FALLS BELOW 21%. IN THE REPORTED COMPLAINT, THERE WAS SUFFICIENT O2 CONCENTRATION PER ADU CALCULATIONS, SINCE THERE HAS BEEN SUFFICIENT FLOW IN THE ADU O2 CHANNEL. THE ADU DOES NOT IDENTIFY OR DETECT WHICH GAS IS FLOWING IN EACH GAS CHANNEL.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT THE ANESTHESIA DELIVERY UNIT (ADU) WAS USED FOR THE FIRST TIME IN A NEW OPERATING ROOM. AN ENT PROCEDURE WAS PERFORMED, UTILIZING A JACKSON REES TYPE CIRCUIT CONNECTED TO THE FRESH GAS PORT OF THE ADU. A PEDI-LITE SENSOR WAS CONNECTED TO THE CIRCUIT THUS AIRWAY GASES AND SPIROMETRY WERE MEASURED. INDUCTION AND MAINTENANCE OF ANESTHESIA WAS PERFORMED WITH FRESH GAS FLOWS OF 3.2 LPM OXYGEN (O2) AND 3.6 LPM NITROUS OXIDE (N2O) ALONG WITH 3.3% SEVOFLURANE. THIS FRESH GAS SETTING RESULTED IN MEASURED AIRWAY GAS CONCENTRATIONS OF 43% O2 AND 54% N2O AT THE PATIENT. AFTER APPROXIMATELY 20 MINUTES, THE EMERGENCE PHASE WAS STARTED, THE VAPORIZER WAS SWITCHED OFF, THE N2O FLOW WAS CLOSED, AND THE O2 FLOW WAS INCREASED TO 6.5 LPM. THE PATIENT DESATURATED AND RESUSCITATION MEASURES WERE TAKEN. AFTER APPROXIMATELY 20 MINUTES, IT WAS DETERMINED THAT THE HOSPITAL SUPPLY OF O2 AND N2O WERE REVERSED. IT WAS SUBSEQUENTLY REPORTED THAT THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANESTHESIA DELIVERY UNIT ANESTHESIA GAS MACHINE BSZ GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Death