BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESUITE CRITICAL CARE MANAGER

    MDR report key: 1581694 · Received December 23, 2009

    Report

    Report Number
    3005244943-2009-00003
    Event Type
    Malfunction
    Date Received
    December 23, 2009
    Report Date
    August 26, 2009
    Manufacturer
    PICIS INC.
    Product Code
    NSX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRELIMINARY INVESTIGATION HAS DETERMINED THE REPORTED ERROR CONDITION IS INTERMITTENTLY BEING TRIGGERED WHEN THE USER ATTEMPTS TO CONNECT AN ADDITIONAL INFORMATION PUMP, WHILE IN THE APPLICATION, THE ORDER '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 AN ADDITIONAL THIRD PARTY INFUSION PUMP TO THE CRITICAL CARE MGR (MEDICAL DEVICE DATA SYSTEM) APPLICATION, THE MANUAL DOCUMENTATION OF ANOTHER PUMP'S "FLUID IN" DATA CHANGED FROM MANUAL TO AUTOMATIC AND RECORDED THE LAST KNOWN DATA VALUE CONTINUOUSLY. THE AUTOMATIC RECORDING OF DATA COULD NOT BE STOPPED. USERS COULD NOT MANUALLY UPDATE THE APPLICATION FOR NEW DOSES OF ADMINISTERED MEDICATION "FLUID IN". NO PT INJURIES HAVE BEEN REPORTED IN CONNECTION WITH THIS ERROR CONDITION. INFUSION OF FLUIDS AND/OR MEDICATION FLUIDS IS NOT INTERRUPTED AT THE INFUSION PUMP. THE ERROR IMPACTS RECORDING OF FLUID BALANCE DATA WITHIN THE CRITICAL CARE MGR APPLICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI THIRD PARTY INFUSION PUMP