BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMIX

    MDR report key: 209834 · Received February 11, 1999

    Report

    Report Number
    MW1015677
    Event Type
    Malfunction
    Date Received
    February 11, 1999
    Date of Event
    February 6, 1999
    Report Date
    February 11, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP. DIV CLINTEC NUTRITION CO.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AUTOMIX TPN COMPOUNDER PROGRAM BY CLINTEC ALLOWS PROTEIN TO BE ORDERED BY WEIGHT. FOR EXAMPLE: 1.7 GM/KG/BAG, EVEN IF NO WEIGHT IS ENTERED IN THE PT INFO SECTION (DEFAULT 0.0KG) RESULTING IN 1.7 GM/KG X 0.0KG = 0 PROTEIN ADDED TO BAG. LABEL PRODUCED CLAIMS 1.7 GM/KG PROTEIN. PT REC'D 2 DAYS OF DEXTROSE/LIPID/ELECTROLYTE ONLY TPN. QUESTIONS OF CALCIUM/PHOSPHATE AND DEXTROSE/LIPID STABILITY PROBLEMS CAUSED BY 09C PROTEIN. WOULD SUGGEST WARNING IN PROGRAMMING FOR ANY WEIGHT BASED INGREDIENT ORDERED IF NO PT WT ENTERED. (ALSO OCCURRED ON 2/7/99.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMIX TPN COMPOUNDER LHI BAXTER HEALTHCARE CORP. DIV CLINTEC NUTRITION CO. MULTITASK 2.30 E *
    2 AUTOMIX TPN COMPOUNDER LHI BAXTER HEALTHCARE CORP DIV CLINTEC NUTRITION CO. MULTITASK 2.30 E *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR