BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD NV MICRODRIP PIGGYBACK SET

    MDR report key: 1083357 · Received July 28, 2008

    Report

    Report Number
    9613251-2008-00283
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 10, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K971293
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. ALL AFFECTED CANADIAN CUSTOMERS WERE NOTIFIED VIA A DEVICE INFO LETTER DATED OCT. 9, 2007. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DIFFICULTY REGULATING FLOW; SUBSEQUENTLY THE PT RECEIVED MORE IV FLUID THAN INTENDED. THE TUBING SET WAS BEING USED TO DELIVER 500ML OF 0.9% SODIUM CHLORIDE AT A RATE OF 40ML/HR. THE CAIR CLAMP WAS USED TO REGULATE THE FLOW RATE. IT WAS REPORTED THAT AFTER 2 HOURS IN USE, THE PT RECEIVED THE 500ML OF SOLUTION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD NV MICRODRIP PIGGYBACK SET 80 FPA FPA HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 TEEN