BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE SHIELD

    MDR report key: 3251390 · Received July 16, 2013

    Report

    Report Number
    3251390
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 11, 2013
    Report Date
    July 16, 2013
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON TRANSPORT TO THE CATH LAB IT WAS NOTED THAT THE IV LINE INFUSING HEPARIN CONTAINED A MIXTURE OF HEPARIN AND BLOOD. WHEN THE IV FLUIDS AND BOLUS DRUGS WHERE CONNECTED TO THE Y PORT LOW ON THE IV LINE IT WAS NOTED THAT THE FLOOR BELOW THE IV PUMP WAS SPATTERED WITH THIS MIXTURE FROM THE IV LINE. A SMALL APPROXIMATELY 1 MM HOLE WAS NOTED IN THE IV LINE NEAR THE IV PUMP AND WAS NOTED TO BE THE SOURCE OF THE BLOOD AND IV FLUID.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ANGIOGRAM.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330445 LIFE SHIELD SET, ADMINISTRATION, INTRAVASCULAR FPA HOSPIRA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR CARDIAC DRUGS| UNKNOWN - THE IV TUBING WAS INFUSING HEPARIN.