BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIGILANCE CONTINUOUS CARDIAC OUTPUT COMPUTER

    MDR report key: 117954 · Received September 5, 1997

    Report

    Report Number
    6000002-1997-00704
    Event Type
    Other
    Date Received
    September 5, 1997
    Date of Event
    August 28, 1997
    Report Date
    September 5, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP., CARDIOVASCULAR GROUP
    Product Code
    DXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING ISSUE WAS DISCOVERED BY A BAXTER SALES REPRESENTATIVE DURING TRAINING USING THE DRUG CALCULATION MODE (SOFTWARE VERSION 5.01). THE ISSUE RELATES TO THE INFUSION RATE CALCULATION, WHICH IS BASED ON SEVERAL FACTORS, ONE OF WHICH IS PT WEIGHT. IF THE WEIGHT IS ENTERED AS KILOGRAMS IN EITHER THE DRUG CALCULATION SCREEN OR PT DATA SCREEN, THE INFUSION RATE CALCULATION WILL BE ACCURATE, HOWEVER, IF THE WEIGHT IS ENTERED AS POUNDS, THE CALCULATION RESULT WILL BE ERRONEOUSLY HIGH. WHILE IT IS STANDARD HOSP PRACTICE TO VERIFY INFUSION RATES, FAILURE TO DO SO COULD LEAD TO AN ERROR IN THE INFUSION RATE. CO IS UNDERTAKING A FIELD CORRECTIVE ACTION TO RESOLVE THIS ISSUE. THE FDA DISTRICT OFFICE IS BEING NOTIFIED OF THE FIELD ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGILANCE CONTINUOUS CARDIAC OUTPUT COMPUTER CONTINUOUS CARDIAC OUTPUT COMPUTER DXG BAXTER HEALTHCARE CORP., CARDIOVASCULAR GROUP VGSSYS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other