BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 2112754 · Received May 26, 2011

    Report

    Report Number
    2112754
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 26, 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

    TOTAL PARENTERAL NUTRITION (TPN) TUBING DISCONNECTED. TPN TUBING BECAME DISCONNECTED FROM CENTRAL LINE. TUBING THAT WAS SAVED LOOKS LIKE IT SPONTANEOUSLY DISCONNECTED AT THE SMART SITE EXTENSION FILTER TUBING FROM THE Y CONNECTOR. RN NOTIFIED MD AND A NEW FLUID ORDER WAS OBTAINED AND THAT FLUID STARTED WHEN ARRIVED ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO