BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION PUMP

    MDR report key: 2250907 · Received August 29, 2011

    Report

    Report Number
    2250907
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 29, 2011
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    CHECKED CHEMOTHERAPY ON PATIENT IN MORNING AND AT CHANGE OF SHIFT. CHEMOTHERAPY NOT INFUSING; NO CHEMOTHERAPY X12. CHANGED PUMPS; WITH NEW PUMP, CHEMOTHERAPY INFUSING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR