BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION PUMP

    MDR report key: 2250908 · Received August 29, 2011

    Report

    Report Number
    2250908
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    August 14, 2011
    Report Date
    August 29, 2011
    Manufacturer
    SIGMA SPECTRUM
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHILE INFUSING A 50ML BAG OF FOSPHENYTOIN, INFUSION PUMP STARTED SIGNALING THAT INFUSION WAS COMPLETE ALTHOUGH THERE WAS STILL 25CC OF MEDICATION LEFT IN THE BAG. COMPLETED INFUSION BY REPEATING THE SAME SETTING. INFUSION REQUIRED 40 MINUTES, RATHER THAN INTENDED 20 MINUTES PER PHARMACY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR