BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITICAL CARE MANAGER

    MDR report key: 2904495 · Received December 5, 2012

    Report

    Report Number
    3005244943-2012-00002
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    October 28, 2012
    Report Date
    November 5, 2012
    Manufacturer
    PICIS INC.
    Product Code
    NSX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION INTO THE REPORTED INCIDENT HAS CONCLUDED THAT THE ROOT CAUSE RESULTED FROM A LIMITATION IN SOFTWARE PERFORMANCE WITHIN THE PICIS PERIOP AND CRITICAL CARE SUITE (ELECTRONIC HEALTH RECORD) OF SOFTWARE APPLICATIONS. OUR FINDINGS HAVE REVEALED THAT CUSTOMERS MAY EXPERIENCE AN ERROR IN PT CASE RECORD DOCUMENTATION FOR MEDICATION ORDER. WHEREBY, AN ORDER MAY FAIL TO BE EXTENDED OR DISCONTINUED IN DOCUMENTATION AT WORKSTATIONS OTHER THAN THE ONE WHERE THIS ACTION WAS TAKEN. THIS ERROR MAY OCCUR DURING A SPECIFIC TIMING OF SOFTWARE SYSTEM EVENTS AND COMBINATION OF DOCUMENTED ACTIONS, AND PRECLUDED BY AN INTERRUPTION IN OUR APPLICATION SYSTEM UPDATE SERVICES THAT IS USUALLY CAUSED BY A NETWORK DISRUPTION. THE ERROR IS ONLY SEEN IN WORKFLOWS WHERE USERS DOCUMENT WITHIN THE SAME PT RECORD AT DIFFERENT WORKSTATIONS. AN INDICATION OF THE ERROR CONDITION WAS OBSERVED ON THE APPLICATION FLOWSHEET DISPLAY BY THE PRESENCE OF A RED STATUS ICON, WHICH IS NORMALLY USED TO INDICATE THE STATUS OF PENDING MEDICATION ORDER TASKS. HOWEVER, WHEN OPENING THE ORDER STATUS WINDOW THE PAGE WAS BLANK DUE TO THE SOFTWARE ERROR. REPORTS OF THIS ERROR CONDITION FROM CLIENTS ARE RARE, AS MULTIPLE SEQUENTIAL CONDITIONS MUST TAKE PLACE. A RESOLUTION TO ADDRESS THE POTENTIAL FOR THIS ERROR IS AVAILABLE IN A CURRENT SOFTWARE SERVICE PACK. THE CUSTOMER WHO REPORTED THE INCIDENT HAS BEEN RECOMMENDED TO UPGRADE TO THE LATEST AVAILABLE SERVICE PACK. PICIS IS PRESENTLY EVALUATING THE NEED TO COMMUNICATE WITH CUSTOMER ABOUT THE POTENTIAL FOR SEEING THIS ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INCIDENT INVOLVING THE CRITICAL CARE MANAGER (ELECTRONIC HEALTH RECORD) SOFTWARE APPLICATION, WHEREBY AN ERROR IN THE ELECTRONIC DOCUMENTATION FOR EXTENDING A MEDICATION ORDER RESULTED WITH A PT MISSING SIX DAYS OF AN ELECTROLYTE MINERAL - NAC1 50MG (SALT). THE INCIDENT DID NOT RESULT IN ANY INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRITICAL CARE MANAGER S/W, TRANSMISSION AND STORAGE PATIENT DATA NSX PICIS INC. 1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI