BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVANCE

    MDR report key: 1221823 · Received November 4, 2008

    Report

    Report Number
    2112667-2008-00044
    Event Type
    Other
    Date Received
    November 4, 2008
    Date of Event
    January 1, 2008
    Report Date
    November 3, 2008
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: AS STATED IN THE AVANCE USERS MANUAL, PREOPERATIVE TESTS SECTION, STEP 2 OF THE LOW PRESSURE LEAK CHECK STATES, "PLUG THE RIGHT-HAND (INSPIRATORY) PORT". ONCE THE TEST IS COMPLETED, THE MANUAL STATES THAT THE USER IS TO "REMOVE THE PLUG IN THE RIGHT-HAND PORT AND RECONNECT THE BREATHING CIRCUIT". THE PLUG IS USED FOR THE LOW PRESSURE LEAK CHECK TO OCCLUDE THE INSPIRATORY PORT. THE PLUG HAS BEEN DESIGNED IN SUCH A WAY TO BE OBVIOUS TO THE USER IF LEFT IN PLACE DURING AN ANESTHETIC. IT IS BRIGHT ORANGE IN COLOR AND HAS A LARGE RING/FLANGE THAT PROTRUDES AROUND THE BREATHING CIRCUIT. IT ALSO IS MADE OF SILICONE AND THUS HAS A DIFFERENT FEEL THAN THE OTHER PORTION OF THE BREATHING SYSTEM. IN ADDITION TO THE VISUAL AND TACTILE CLUES, THERE IS A CASCADE OF HIGH PRIORITY SYSTEM ALARMS, BOTH AUDIBLE AND VISUAL, THAT OCCUR IF THE TEST DEVICE IS LEFT IN THE BREATHING CIRCUIT DURING A CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED STUDENT CRNA UTILIZED RED PLUG FOR PERFORMING THE LOW P LEAK TEST, HOWEVER, DID NOT REMOVE PLUG PRIOR TO CONNECTING THE BREATHING CIRCUIT. AT START OF CASE, CLINICIAN HAD DIFFICULTY VENTILATING PT. THE PLUG WAS NOTICED, REMOVED, AND THE CASE CONTINUED WITH NO FURTHER REPORTED PROBLEM. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANCE ANESTHESIA MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1