BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE

    MDR report key: 2073515 · Received April 18, 2011

    Report

    Report Number
    2073515
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 18, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    IV TUBING FOUND LYING IN BED DISCONNECTED FROM PATIENT. INTRALIPIDS (TPN) AND INTRALIPIDS STOPPED. IT IS UNCLEAR WHERE DISCONNECT OCCURRED ON TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE INTRAVASCULAR TUBING FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO