BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE

    MDR report key: 6092401 · Received November 10, 2016

    Report

    Report Number
    6092401
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 26, 2016
    Manufacturer
    CAREFUSION 303, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE GETTING READY TO HANG IV FLUIDS ON PATIENT BUT IV TUBING WOULD NOT PRIME. THE IV TUBING WAS DISCARDED AND A NEW SET THAT WORKED WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743352 SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC

    Patients

    Seq Age Sex Outcome Treatment
    1