BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR

    MDR report key: 1003948 · Received January 30, 2008

    Report

    Report Number
    1003948
    Event Type
    Malfunction
    Date Received
    January 30, 2008
    Date of Event
    January 27, 2008
    Report Date
    January 30, 2008
    Manufacturer
    HOSPIRA GLOBAL MEDICAL AFFAIRS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS CONNECTED TO THREE GEMSTAR PUMPS FOR DOXORUBICIN, CYTOXAN, AND MESNA. WHEN THE PUMP WAS INFUSING MESNA, THE TUBING OF THE MESNA INFUSION STARTED LEAKING FROM THE INFUSION SITE.====================== MANUFACTURER RESPONSE FOR TUBING, IV, GEMSTAR======================REPRESENTATIVE IS AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR TUBING, IV FPA HOSPIRA GLOBAL MEDICAL AFFAIRS * 571635H

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR CHEMOTHERAPY| CHEMOTHERAPY