BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV ADMINISTRATION SET

    MDR report key: 1240744 · Received August 21, 2008

    Report

    Report Number
    1221261-2008-00032
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 24, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT WAS TRANSFUSED WITH BLOOD WITHOUT ANY ISSUE, WITHOUT ANY ALARM. THEN THE PT WAS MOVED TO HAVE A SCAN. BACK IN THE ROOM, THE NURSE TURNED ON THE H1000. AT THIS MOMENT, SHE SAW BLOOD UNDER THE EQUIPMENT AND IN THE WATER RESERVOIR OF THE H1000. SHE STOPPED THE TRANSFUSION. IN THE RESERVOIR, THERE WAS 1.7L OF MIX (WATER+BLOOD). AT THIS TIME, THE PT HAS NO INFECTION SYMPTOMS. EVENT OCCURRED IN OTHER COUNTRY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * LEVEL 1 FLUID WARMER H1000: LOT 20000279