BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRONIX COMPOUNDER/BAXTER

    MDR report key: 500616 · Received December 12, 2003

    Report

    Report Number
    500616
    Event Type
    Death
    Date Received
    December 12, 2003
    Date of Event
    October 28, 2003
    Report Date
    December 11, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP, MEDICATION DELIVERY, CLINTEC NUTRITION.
    Product Code
    LHI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VERY PREMATURE PT RECEIVING HYPERALIMENTATION. PT SODIUM LEVELS WERE NOTED TO BE ELEVATED. THEY REQUIRED AN EXCHANGE TRANSFUSION. THEY DIED 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRONIX COMPOUNDER/BAXTER * LHI BAXTER HEALTHCARE CORP, MEDICATION DELIVERY, CLINTEC NUTRITION. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DAY Death| R