BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMITHS MEDICAL MD, INC.

    MDR report key: 790289 · Received December 1, 2006

    Report

    Report Number
    790289
    Event Type
    Death
    Date Received
    December 1, 2006
    Date of Event
    August 22, 2006
    Report Date
    November 27, 2006
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT WITH LIPIDS INFUSING HAD ELEVATED TRIGLYCERIDES OF 2546 REPORTED AT 0615 BLOOD DRAW IN 2006. LIPID RATES WERE REPORTED TO BE APPROPRIATE IN TERMS OF ORDERING RATE, DELIVERY RATE, AND DOCUMENTATION ON MEDICAL RECORD. LIPIDS WERE DISCONTINUED AFTER LEARNING LAB RESULTS. TRIGLYCERIDE LEVEL AT 1817 THAT SAME DAY WAS 771. INFANT DEVELOPED RENAL FAILURE AND RESPIRATORY FAILURE AND EXPIRED EARLY THE NEXT MORNING. A REASON FOR THE HYPERLIPIDEMIA COULD NOT BE FOUND. TUBING WAS NOT AVAILABLE FOR EVALUATION AND THE PUMP VERIFIED THAT THE RATE WAS SET PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITHS MEDICAL MD, INC. MEDFUSION 3500 INFUSION PUMP FRN SMITHS MEDICAL MD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DAY Death