BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV ADMINISTRATION SET

    MDR report key: 1020768 · Received March 4, 2008

    Report

    Report Number
    1221261-2008-00006
    Event Type
    Malfunction
    Date Received
    March 4, 2008
    Report Date
    February 4, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THEY HAD ONE EVENT INVOLVING AN IV ADMINISTRATION SET THAT HAD LEAKAGE OF SALT SOLUTION FROM THE HEAT EXCHANGER. NO ADVERSE OUTCOME TO PT. EVEN OCCURRED AT AZIENDA OSPEDALIERA PADOVA - LATINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IV ADMINISTRATION SET 80FPA IV ADMINISTRATION SET FPA SMITHS MEDICAL ASD, INC. * 1215578

    Patients

    Seq Age Sex Outcome Treatment
    1 * H-1200 FAST FLOW FLUID BLOOD WARMER