BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOMIX 3+3/AS COMPOUNDER

    MDR report key: 445559 · Received February 21, 2003

    Report

    Report Number
    6000001-2003-02254
    Event Type
    Other
    Date Received
    February 21, 2003
    Date of Event
    February 1, 2003
    Report Date
    February 4, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    70% DEXTROSE STATION WAS PROGRAMMED AS THE SPECIFIC GRAVITY BEING 1.20 INSTEAD OF 1.24. THE AMINO ACID STATION WAS PROGRAMMED FOR 1.03 INSTEAD OF 1.02 SPECIFIC GRAVITY. 13 TPN'S HAD BEEN COMPOUNDED WITH THIS INFORMATION ENTERED INCORRECTLY. MOS SOFTWARE WAS NOT IN USE AND THE PHARMACY WAS IN TRAINING WHEN THE INCIDENT OCCURRED. THE PHARMACY WAS ADVISED TO DISCARD THE BAGS. HOWEVER THE PHARMACIST STATED THEY WOULD CALCULATE THE DIFFERENCE IN THE GRAMS WEIGHT AND PASS THE BAGS THAT ARE WITHIN 5%. THE PHARMACY WAS AGAIN ADVISED TO DISCARD THE BAGS. IT IS NOT KNOWN IF THE BAGS WERE DISCARDED. NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMIX 3+3/AS COMPOUNDER I.V. SOLUTION COMPOUNDER LHI BAXTER HEALTHCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other