BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 13000

    MDR report key: 2060126 · Received April 5, 2011

    Report

    Report Number
    2060126
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 11, 2011
    Report Date
    April 5, 2011
    Manufacturer
    HOSPIRA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HOOKED UP TO A FLUOROURACIL (5FU) HOME INFUSION PUMP. IT WAS TO RUN FOR 46 HOURS, BUT FINISHED 7 HOURS EARLY. THE PUMP STARTED BEEPING & IT WAS NOTED THAT THE IV BAG WAS EMPTY SO THE PUMP WAS STOPPED & DISCONNECTED BY PATIENT'S WIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR 13000 INFUSION PUMP FRN HOSPIRA GEMSTAR 13000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR CHEMOTHERAPY