BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARESUITE ANESTHESIA MANAGER

    MDR report key: 1812602 · Received August 19, 2010

    Report

    Report Number
    3005244943-2010-00005
    Event Type
    Other
    Date Received
    August 19, 2010
    Report Date
    July 27, 2010
    Manufacturer
    PICIS INC.
    Product Code
    NSX
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION INTO THE REPORTED INCIDENT HAS CONCLUDED THAT THE ROOT CAUSE IS USER ERROR. THERE WAS NO MALFUNCTION OF PICIS ANESTHESIA MANAGER APPLICATION OR SUPPORTED 3RD PARTY DEVICE DRIVERS. IN THE COURSE OF PICIS' REVIEW OF THE INCIDENT WITH THE CUSTOMER, THE CUSTOMER ACKNOWLEDGED THEIR RESPONSIBILITY FOR THE ERROR. THE CUSTOMER WANTED TO MAKE EACH MFR AWARE OF THE SITUATION AND TO FURTHER REVIEW AVAILABLE DOCUMENTATION. THE CLIENT HAS SINCE CORRECTED THE DRIVER CONFIGURATION MANAGEMENT FILE ERROR IN THEIR OPERATING ROOM CARE AREA. DURING THE COURSE OF OUR INTERNAL INVESTIGATION, WE HAVE REVIEWED OUR IMPLEMENTATION TRAINING PROCESS AND AVAILABLE INSTRUCTIONS FOR CREATING DEVICE DRIVER CONFIGURATION MANAGEMENT FILES. WE BELIEVE THAT THE PROCESS FOR MANAGING DEVICE DRIVER COMMUNICATION PORT CONFIGURATIONS IS APPROPRIATE. THEREFORE, NO CORRECTIVE ACTION(S) ARE NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INCIDENT INVOLVING PICIS ANESTHESIA MANAGER ELECTRONIC HEALTH RECORD APPLICATION, USED IN CONNECTION WITH THEIR 3RD PARTY ANESTHESIA DELIVERY MACHINE FOR THE PURPOSE OF DOCUMENTING DEVICE VARIABLES. THE INCIDENT WAS REPORTED TO THE DEVICE MFRS AS A PRECAUTIONARY MEASURE. THE CUSTOMER HAS ACKNOWLEDGED INTRODUCING A WRONG DRIVER CONFIGURATION FILE, USED TO ESTABLISH DRIVER COMMUNICATION BETWEEN OPTIONAL 3RD PARTY MEDICAL DEVICE AND THE WORKSTATION COMMUNICATION PORTS THAT EACH DEVICE DRIVE USES TO COMMUNICATE. THE CONFIGURATION FILE WAS CREATED FOR THEIR PACU AND SUBSEQUENTLY COPIED BY THE CUSTOMER TO THEIR OPERATING ROOM WORKSTATIONS, WHERE A DIFFERENT DEVICE CONFIGURATION WAS IN PRACTICE (I.E. PACU HAS PATIENT MONITORS ON COMMUNICATION PORT 4 AND OPERATING ROOM USES COMMUNICATION PORT 4 FOR ANESTHESIA MACHINES). ON START UP, OUR ANESTHESIA MANAGER APPLICATION INITIATED COMMUNICATION ("HANDSHAKE" ACKNOWLEDGEMENT) WITH THE ANESTHESIA MACHINE, USING A DRIVER INTENDED FOR COMMUNICATION WITH A PATIENT MONITOR TYPE DEVICE. THE DATA EXCHANGED (212 BITS FOR MONITOR VS 6 BITS FOR ANESTHESIA MACHINES) CAUSED THE ANESTHESIA MACHINE TO CRASH, WITH A MEMORY OVERLOAD ERROR CODE. CLINICAL INTERVENTION WAS NECESSARY TO CONTINUE WITH THE PROCEDURE. THERE WERE NO PATIENT INJURIES REPORTED.

    Devices

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

    Patients

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