BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITICAL CARE MANAGER

    MDR report key: 2276061 · Received September 8, 2011

    Report

    Report Number
    3005244943-2011-00005
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    PICIS INC.
    Product Code
    NSX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE INVESTIGATED AND CONFIRMED THE REPORTED PROBLEM. THE ERROR CAN BE SEEN WITH PTS WHO ARE TRANSFERRED WITHIN THE CUSTOMER'S NETWORK OF MEDICAL FACILITIES THAT SHARE A COMMON SERVER AND DATABASE FOR THE CRITICAL CARE MANAGER EHR (ELECTRONIC HEALTH RECORD) APPLICATION. THE ERROR CONDITION IS BROUGHT ON BY A CUSTOMER SPECIFIC REQUIREMENT FOR HAVING A UNIQUE PT IDENTIFICATION NUMBERING AND RECORD LOCATOR SYSTEM, AND WHERE THE DUPLICATION OF ASSIGNED ID NUMBERS IS ALLOWED AND SEEN IN PRACTICE BETWEEN NETWORK FACILITIES. A PT WHO IS NOW AN ACTIVE ADMISSION IN THE RECEIVING FACILITY (2) HAS BEEN A SYSTEM REQUEST MADE BETWEEN PICIS APPLICATION AND THE CUSTOMER'S HIS AT THE FIRST FACILITY (1). PICIS APPLICATION LOGIC NOW UPDATES THE PT'S ACTIVE RECORD IN THE DATABASE WITH THE PT'S ORIGINAL ID NUMBER ASSIGNED AT FACILITY 1, WHICH ALREADY IS ASSIGNED TO ANOTHER PT AT FACILITY 2. THE ACTIVE RECORD IS NOW UPDATED WITH HEALTH INFO FROM THE OTHER PT AT FACILITY 2. THIS UPDATE CAN AFFECT DEMOGRAPHIC AND ALLERGIES AND PRECAUTIONS DATA FOR TRANSFERRED PTS. ROOT CAUSE: OUR INVESTIGATION HAS CONCLUDED THAT THE ROOT CAUSE FOR THIS ERROR CONDITION IS THE RESULT OF A CUSTOMER REQUIREMENT FOR A UNIQUE PT ID NUMBERING AND RECORD LOCATOR WITHIN A GIVEN FACILITY THAT DID NOT TAKE INTO ACCOUNT THE POSSIBILITY OF DUPLICATES ACROSS FACILITIES. THE POTENTIAL FOR THIS ERROR IS SPECIFIC TO THE REPORTING CUSTOMER AND THEIR NETWORK OF MEDICAL FACILITIES. OTHER CUSTOMERS WITHIN OUR INSTALLED BASE ARE NOT AFFECTED BY THIS ISSUE. CORRECTIVE ACTION(S): THE FOLLOWING CORRECTIVE MEASURES HAVE BEEN DEPLOYED OR ARE IN PROCESS TO PREVENT FURTHER OPPORTUNITY FOR THIS ERROR TO BE EXPERIENCED: A SAFETY NOTIFICATION LETTER WAS DISTRIBUTED ON AUGUST 12TH TO ALL POTENTIALLY AFFECTED FACILITIES WITHIN THE CUSTOMER'S NETWORK OF MEDICAL FACILITIES. IN COOPERATION WITH THE CUSTOMER, OUR STAFF HAD DEVELOPED NEW REQUIREMENTS FOR CORRECT HANDLING OF ELECTRONIC HEALTH RECORD UPDATES FOR DISCHARGED PTS AND FOR PTS WHO ARE TRANSFERRED BETWEEN FACILITIES. FACILITIES RUNNING PICIS EHR APPLICATION IN THEIR LIVE ENVIRONMENT AND WHERE PT TRANSFERS ARE IN PRACTICE, HAVE RECEIVED AND SUCCESSFULLY IMPLEMENTED A SOFTWARE SOLUTION UPDATE. PICIS WILL COORDINATE IMPLEMENTATION OF THE SOFTWARE SOLUTION IN THOSE FACILITIES THAT ARE NOT YET RUNNING OUR APPLICATION ON THEIR LIVE ENVIRONMENT AND WHERE PT TRANSFERS ARE NOT IN PRACTICE AT THIS TIME. PICIS WILL MONITOR THE FIELD CORRECTION THROUGH COMPLETION OF ALL REQUIRED ACTIONS.

    Description of Event or Problem · 1

    A CUSTOMER HAS REPORTED VIEWING THE INCORRECT PT'S HEALTH RECORD WITHIN THE CRITICAL CARE MANAGER (ELECTRONIC HEALTH RECORD) APPLICATION. THE ERROR WAS SEEN WITH PTS WHO WERE TRANSFERRED WITHIN THE CUSTOMER'S NETWORK OF MEDICAL FACILITIES AND WHO WERE ASSIGNED THE SAME PT IDENTIFICATION NUMBER AT TWO DIFFERENT FACILITIES. THE PT IDENTIFICATION NUMBERING SYSTEM DEPLOYED BY THE CUSTOMER HAS COMPARABLE PT ID NUMBERS ASSIGNED IN EACH FACILITY. WHEN VIEWING A TRANSFERRED PT'S DISCHARGED RECORD IN CRITICAL CARE MANAGER THE TRANSFERRED PTS' RECORD WAS OVERWRITTEN WITH HEALTH INFO OF ANOTHER PT, WHO HAD BEEN ASSIGNED THE SAME ID NUMBER. THERE HAVE BEEN NO REPORTS OF PT IMPACT OR INJURY AS A RESULT OF THIS ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1