BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 2444657 · Received January 23, 2012

    Report

    Report Number
    2444657
    Event Type
    Malfunction
    Date Received
    January 23, 2012
    Date of Event
    January 21, 2012
    Report Date
    January 23, 2012
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    LIPIDS ADMINISTERED AT 21ML/HOUR IN 250ML/BAG. BEGAN LIPIDS AT 2030 AND WERE INTENDED TO RUN UNTIL 0830 THE FOLLOWING MORNING; HOWEVER, INFUSION COMPLETED AT 0400. PUMP INDICATED THAT IT WAS RUNNING AT 21ML/HOUR. HOWEVER, IT APPEARS TO HAVE BEEN RUNNING AT A FASTER INFUSION RATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR