BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESUITE CRITICAL CARE MANAGER

    MDR report key: 2263139 · Received August 18, 2011

    Report

    Report Number
    3005244943-2011-00002
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 31, 2011
    Manufacturer
    PICIS INC.
    Product Code
    NSX
    PMA / PMN Number
    NA
    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 WITHOUT THE IDENTIFICATION OF A ROOT CAUSE, FOR THE REPORTED INCIDENT. DURING OUR F/U INVESTIGATION WITH THE CUSTOMER WE WERE UNABLE TO REPLICATE THE REPORTED ERROR IN THE CUSTOMER SYSTEM. NOR, WERE WE ABLE TO RETRIEVE ANY ADDITIONAL INFO OR ERROR CONDITIONS TO HELP SUPPORT FURTHER INTERNAL INVESTIGATION. WE CONTINUED WITH OUR F/U EFFORTS WITH THE CUSTOMER, BUT THE ERROR HAS ONLY BEEN SEEN ONE TIME AND THE CLIENT ACCEPTED CLOSING THE SERVICE CALL. A COMPLAINT INVESTIGATION WILL BE REOPENED IF NEW INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN EVENT, WHEREBY, A DOCUMENTED MEDICATION ORDER IN THE CRITICAL CARE MANAGER (ELECTRONIC HEALTH RECORD) SOFTWARE APPLICATION NO LONGER SHOWED MEDICATION TASKS FOR VALIDATION ON AN ACTIVE ORDER. THERE WAS A MEDICATION ORDER MADE FOR DOMPERIDON. THE ORDER IN THE APPLICATION SHOWED TASKS FOR 14 DAYS AND AFTER THAT THERE WERE NO FURTHER TASKS SHOWING FOR VALIDATING ACTIVE MEDICATION ORDER. DUE TO THIS ERROR, A PT MISSED A DOSE OF DOMPERIDON BEFORE THE ERROR WAS CAUGHT. THERE WERE NO REPORTS OF IMPACT OR INJURY TO THE PT AS A RESULT OF THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other