BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVANCE

    MDR report key: 1267816 · Received December 8, 2008

    Report

    Report Number
    2112667-2008-00049
    Event Type
    Other
    Date Received
    December 8, 2008
    Date of Event
    November 10, 2008
    Report Date
    December 8, 2008
    Manufacturer
    DATEX-OHMEDA INC.
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    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. TO HELP ENSURE THAT THE USER REMOVES THE PLUG FROM THE INSPIRATORY PORT FOLLOWING CONCLUSION OF THE LOW P LEAK PREOPERATIVE CHECKOUT TEST, THE (B) (4) SOFTWARE HAS BEEN MODIFIED TO INSTRUCT THE USER TO REMOVE THE PLUG AT THE CONCLUSION OF THE LOW P LEAK CHECKOUT TEST. THESE INSTRUCTIONS ARE DISPLAYED REGARDLESS OF WHETHER OR NOT THE LOW P LEAK CHECK PASSES, FAILS, OR IS CANCELLED BY THE USER. THE NEW INSTRUCTIONS ARE "REMOVE THE PLUG FROM THE RIGHT-HAND PORT. RECONNECT THE PATIENT CIRCUIT. SELECT THE BACK BUTTON." WHEN THE USER PRESSES THE BACK BUTTON, THE (B) (4) SOFTWARE ALSO NOW PERFORMS AN AUTOMATED CHECK TO VERIFY THAT THE PLUG HAS BEEN REMOVED. THIS CHECK FLOWS GAS AND LOOKS FOR AN INCREASE IN PRESSURE. IF THIS CHECK DETERMINES THAT THE PLUG IS STILL IN THE INSPIRATORY PORT, THE SOFTWARE WILL DISPLAY THE FOLLOWING MESSAGE TO THE USER: "THERE IS A PLUG IN THE RIGHT-HAND PORT. REMOVE THE PLUG FROM THE RIGHT-HAND PORT. RECONNECT THE PATIENT CIRCUIT. SELECT THE ACCEPT BUTTON." IF THE CHECK IS UNABLE TO DETERMINE WHETHER OR NOT THE PLUG IS STILL INSERTED, DUE TO A PROBLEM SUCH AS A LOSS OF GAS SUPPLY, THE SOFTWARE WILL DISPLAY THE FOLLOWING MESSAGE TO THE USER: "IS THE PLUG INSERTED? REMOVE THE PLUG FROM THE RIGHT-HAND PORT. RECONNECT THE PATIENT CIRCUIT. SELECT THE ACCEPT BUTTON." IN ADDITION, WHEN THESE MESSAGES ARE SHOWN INSTRUCTING THE USER TO REMOVE THE PLUG FROM THE INSPIRATORY PORT, A PICTURE IS ALSO DISPLAYED THAT HELPS GUIDE THE USER TO PART OF THE MACHINE WHERE THE INSPIRATORY PORT AND PLUG ARE LOCATED.

    Description of Event or Problem · 1

    CUSTOMER INADVERTENTLY LEFT THE TEST PLUG IN THE INSPIRATORY PORT AND CONNECTED A PATIENT CIRCUIT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1