BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESHIELD

    MDR report key: 1013927 · Received March 14, 2008

    Report

    Report Number
    MW5005888
    Event Type
    Other
    Date Received
    March 14, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 3, 2008
    Manufacturer
    HOSPIRA INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IV TUBING ROLLER CLAMPS CAUSE EITHER RAPID OR NO FLOW INFUSION. UNABLE TO REGULATE THE FLOW. MATERIALS MGMT CONTACTED THE COMPANY REP IN 2008 ABOUT THIS ISSUE. THE HOSPITAL PULLED ALL OF THESE PRIMARY IV SETS WITH THIS LOT NUMBER. ONE OF THE LOT NUMBER PRODUCTS IS AVAILABLE. NO HARM CAME TO THE PT. THE RN REPORTING INDICATED THAT THIS WAS NOT AN ISOLATED EVENT, UNFORTUNATELY, THE IV SETS USED THAT WERE REPORTED AS FAILING WERE NOT SAVED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD PRIMARY IV SET FPA HOSPIRA INC PB-1230 56 001 4W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other