BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESUITE CRITICAL CARE MANAGER

    MDR report key: 1581692 · Received December 23, 2009

    Report

    Report Number
    3005244943-2009-00004
    Event Type
    Malfunction
    Date Received
    December 23, 2009
    Report Date
    April 15, 2009
    Manufacturer
    PICIS, INC.
    Product Code
    NSX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRELIMINARY INVESTIGATION HAS DETERMINED THE REPORTED ERROR CONDITION IS INTERMITTENTLY BE TRIGGERED WHEN THE USER ATTEMPTS TO CONNECT AN INFUSION PUMP, WHILE IN THE APPLICATION THE ORDERS 'DOCUMENT AN ACTION" WINDOW IS OPEN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CONNECTING A THIRD PARTY INFUSION PUMP TO THE CRITICAL CARE MANAGER (MEDICAL DEVICE DATA SYSTEM) APPLICATION, THE MANUAL DOCUMENTATION OF PT "FLUID OUT" DATA CHANGED FROM MANUAL ENTRY IN THE APPLICATION TO AUTOMATIC AND CONTINUOUS RECORDING OF THE LAST DATA ENTERED. THE AUTOMATIC RECORDING COULD NOT BE STOPPED. USERS COULD NOT MANUALLY UPDATE APPLICATION WITH REAL-TIM "FLUID OUT" DATA. NO PT INJURIES HAVE BEEN REPORTED IN CONNECTION WITH THIS ERROR CONDITION. THE ERROR IMPACTS RECORDING OF PT "FLUID OUT" DATA WITHIN THE CRITICAL CARE MANAGER APPLICATION.

    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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI THIRD PARTY INFUSION PUMP