BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD

    MDR report key: 1843429 · Received August 30, 2010

    Report

    Report Number
    1843429
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 30, 2010
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US

    Narratives

    Description of Event or Problem · 1

    DURING IV INFUSION, THE NURSE NOTICED THE IV WAS LEAKING. UPON INSPECTION, IT WAS NOTED THE MICRO FILTER APPEARED TO BE LEAKING FROM A PIN HOLED ON THE PLASTIC FILTER CASING. THIS WAS NOTED TO OCCUR WHILE THE FLUID WAS BEING PUMPED. THE IV WAS DISCONTINUED, THERE WAS NO HARM TO THE PATIENT. THE FACILITY DOES PLAN TO CONTACT THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD INFUSION SET FPA HOSPIRA * 811355H

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO