BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 1901014 · Received October 18, 2010

    Report

    Report Number
    1901014
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 18, 2010
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT'S CHEMOTHERAPY WAS SET FOR ONE HOUR AND THE PUMP PUT IT IN OVER 45 MINUTES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR