BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE

    MDR report key: 2161740 · Received July 11, 2011

    Report

    Report Number
    2161740
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS RECEIVING TOTAL PARENTERAL NUTRITION (TPN), LIPIDS AND ANTIBIOTICS. THE LIPID LINE STARTED TO BACK UP. THE MICROCLAVE WAS REPLACED 8 TIMES AND STILL CONTINUED TO BACK UP IN THE LIPID LINE. THE PRODUCT WAS REMOVED AND THE LIPIDS INFUSED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCLAVE MICROCLAVE FPA ICU MEDICAL, INC B3300 2203268

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO OTHER