BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 5061651 · Received September 1, 2015

    Report

    Report Number
    MW5056019
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 12, 2015
    Report Date
    September 1, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CYCLIC TPN DISCOVERED DISCONNECTED (B)(6). MC100 CHANGED (B)(6). SMARTSITE EXTENSION SET 20028E, LOT NUMBER 15046695 WAS FOUND DISCONNECTED FROM THE ICU MEDICAL MICROCLAVE MC100 NEUTRAL CONNECTOR, LOT NUMBER 3053029. SMALL AMOUNT OF TPN LEAKED OUT. THERE WAS A BRIEF INTERRUPTION OF TREATMENT. NO HARM TO PATIENT OR INTERVENTION REQUIRED. REPORTED TO CAREFUSION AND ICU MEDICAL. PRODUCTS SENT TO CAREFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579799 SMARTSITE EXTENSION SET SMARTSITE EXTENSION SET FPA CAREFUSION 20028E 15046695

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR