BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART SET INFUSION SET

    MDR report key: 856774 · Received May 16, 2007

    Report

    Report Number
    856774
    Event Type
    Malfunction
    Date Received
    May 16, 2007
    Date of Event
    April 8, 2007
    Report Date
    May 16, 2007
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE IV TUBING CAME APART AND LEAKED FLUID (TPN). THE ALARM ON THE IV PUMP DID NOT SOUND. THE IV PUMP INFORMATION WAS NOT INCLUDED IN THE REPORT SO UNABLE TO PROVIDE. THE IV TUBING WAS CHANGED AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART SET INFUSION SET TUBING, IV FPA ALARIS MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR