BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANESTHESIA MANAGER

    MDR report key: 2589834 · Received May 15, 2012

    Report

    Report Number
    3005244943-2012-00001
    Event Type
    Injury
    Date Received
    May 15, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 6, 2012
    Manufacturer
    PICIS INC.
    Product Code
    NSX
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION INTO THE REPORTED INCIDENT HAS CONCLUDED THAT THE ROOT CAUSE WAS A RESULT OF USER ERROR. THERE WAS NO MALFUNCTION ON THE PART OF PICIS ANESTHESIA MANAGER SOFTWARE APPLICATION OR SUPPORTED 3RD PARTY DEVICE SOFTWARE DRIVERS. ANESTHESIA MANAGER IS AN ELECTRONIC HEALTH RECORD SYSTEM WHICH CAN BE CONFIGURED THROUGH SOFTWARE DRIVERS TO RECEIVE AND DOCUMENT DATA EXPORTED FROM 3RD PARTY DEVICES, SUCH AS THE AESTIVA ANESTHESIA MACHINE. COMMUNICATION IS ESTABLISHED THROUGH SERIAL PORT CONNECTION IN CUSTOMER WORKSTATIONS INSTALLED WITH ANESTHESIA MANAGER AND SOFTWARE DEVICE DRIVERS USING STANDARD COMMUNICATION PROTOCOLS. METHOD - IN THE COURSE OF OUR INITIAL INVESTIGATION WITH THE CUSTOMER ON (B)(6) OF THIS YEAR, WE LEARNED THAT THE ERROR WAS INADVERTENTLY INTRODUCED BY THE CUSTOMER'S INTERNAL IT SYSTEM ADMINISTRATOR ASSIGNED TO PICIS SOFTWARE. THE ERROR OCCURRED FOLLOWING ROUTINE UPDATES MADE TO THE WORKSTATION GOLDEN CONFIGURATION FILES. PICIS HELPED TO IDENTIFY THAT AN UNINTENDED GOLDEN CONFIGURATION FILE FOR DEVICE DRIVERS WAS ALSO PUSHED OUT TO ANESTHESIA MANAGER WORKSTATIONS IN SIX OPERATING ROOM'S, WHERE A DIFFERENT 3RD PARTY DEVICE/SERIAL PORT ASSIGNMENT WAS IN PLACE. THE ERROR IN DEVICE DRIVER CONFIGURATION TO WORKSTATION SERIAL PORT ASSIGNMENT LED TO A DIFFERENT DRIVER COMMUNICATION PROTOCOL ON THE PORT WHERE THE AESTIVA ANESTHESIA MACHINES WERE CONNECTED. IT IS UNKNOWN WHY THE 3RD PARTY ANESTHESIA MACHINES FAILED TO PERFORM THEIR INTENDED FUNCTION UNDER THE CIRCUMSTANCES. DURING THE COURSE OF OUR INVESTIGATION, WE HAVE REVIEWED OUR IMPLEMENTATION TRAINING PROCESS AND AVAILABLE INSTRUCTIONS FOR CREATING DEVICE DRIVER CONFIGURATION MANAGEMENT FILES. PICIS BELIEVES THAT THE PROCESS FOR MANAGING DEVICE DRIVER COMMUNICATION PORT CONFIGURATIONS IS APPROPRIATE. NO CORRECTIVE ACTION(S) IS NEEDED AT THIS TIME. PICIS HAS PROVIDED SUPPORT TO THE CUSTOMER IN THEIR EFFORTS TO UNDERSTAND AND CORRECT THE ERROR.

    Description of Event or Problem · 1

    AN INVESTIGATION INTO THE USER-FACILITY MEDWATCH REPORT ((B)(4)), CONFIRMS OUR PRIOR RECEIPT AND INVESTIGATION INTO THE CUSTOMER REPORTED ISSUE, ON (B)(6) OF THIS YEAR. THE CUSTOMER REPORTED A SINGLE DAY EVENT INVOLVING SIX 3RD PARTY AESTIVA ANESTHESIA MACHINES RESETTING WHILE PHYSICALLY CONNECTED TO WORKSTATIONS INSTALLED WITH PICIS' ANESTHESIA MANAGER ((B)(4)) SOFTWARE APPLICATION. THE ANESTHESIA MACHINE MALFUNCTION WAS OBSERVED UPON START UP OF THE PICIS ANESTHESIA MANAGER APPLICATION IN SIX OPERATING ROOMS. THE CUSTOMER REPORTED THAT THE ERROR WAS CAUSED BY THE PHYSICAL CONNECTION BETWEEN THE DEVICES. THE SERIAL PORT CONNECTION WAS REMOVED AND NO FURTHER ERRORS WERE SEEN ON THE 3RD PARTY ANESTHESIA MACHINES. THE ERROR WAS REPORTED TO PICIS TO AIDE IN THE IDENTIFICATION OF ROOT CAUSE. THERE WERE NO REPORTS OF PATIENT INJURY AS A RESULT OF THIS SINGLE DAY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANESTHESIA MANAGER S/W, TRANSMISSION & STORAGE PATIENT DATA NSX PICIS INC. 4220 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention "AESTIVA" - ANESTHESIA MACHINE