BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESUITE CRITICAL CARE MANAGER

    MDR report key: 2107421 · Received May 20, 2011

    Report

    Report Number
    3005244943-2011-00001
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Report Date
    March 18, 2011
    Manufacturer
    PICIS INC.
    Product Code
    NSX
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION INTO THE REPORTED INCIDENT HAS CONCLUDED THAT THE ROOT CAUSE RELATES TO AN ERROR CONDITION INVOLVING THE ANESTHESIA, PACU AND CRITICAL CARE MODULES IN CARESUITE FAMILY OF ELECTRONIC HEALTH RECORD SOFTWARE APPLICATIONS. THE FINDINGS REVEAL THAT CUSTOMERS MAY EXPERIENCE AN ERROR IN UPDATING APPLICATION DOCUMENTATION FOR EXTENDING MEDICATION ORDERS. THIS ERROR ONLY OCCURS DURING A SPECIFIC TIMING OF CONDITIONS, WHEN TWO USERS ARE SIMULTANEOUSLY UPDATING THE SAME PT MEDICATION RECORD, OPEN AT TWO DIFFERENT WORKSTATIONS. IN ORDER TO TRIGGER THE ERROR, ONE CLINICIAN MUST FIRST OPEN THE PT MEDICATION RECORD AT THE PT BEDSIDE WORKSTATION AND BE DOCUMENTING THE FINAL DOSAGE OF AN ORDER, WHEN A SECOND CLINICIAN SUBSEQUENTLY OPENS THE SAME PT RECORD FROM A REMOTE WORKSTATION AND SIMULTANEOUSLY EXTENDS THAT SAME MEDICATION ORDER. UNDER THESE CONDITIONS, DOCUMENTING THE FINAL DOSAGE OF AN ORDER COMPLETES THE ORDER, WHICH TAKES PRECEDENCE OVER EXTENDING THE ORDER. THE ORDER IS THEN MARKED AS "DONE" AT THE BEDSIDE WORKSTATION. REPORTS OF THIS ERROR CONDITION FROM CLIENTS ARE RARE. WE CONSIDER THE ERROR UNLIKELY TO BE EXPERIENCED BY USERS, BECAUSE OF THE SEQUENTIAL CONDITIONS THAT MUST BE PRESENT. A RESOLUTION TO ADDRESS THE POTENTIAL FOR THIS ERROR WILL BE MADE AVAILABLE IN A FUTURE SOFTWARE SERVICE PACK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INCIDENT INVOLVING CRITICAL CARE MANAGER (ELECTRONIC HEALTH RECORD) SOFTWARE APPLICATION, WHEREBY AN ERROR IN THE DOCUMENTATION PROCESS FOR EXTENDING A MEDICATION ORDER RESULTED WITH A PT MISSING THREE DOSES OF AN ANTIBIOTIC. CUSTOMER REPORTED THAT THERE WAS NO INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other