BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 3250766 · Received June 6, 2013

    Report

    Report Number
    3250766
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 6, 2013
    Manufacturer
    CAREFUSION 303, INC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    USING THE ALARIS INFUSION SYSTEM, CONSIST OF PCU (8015) AND 4 INFUSION MODULES (8100). STAFF WAS NOTIFIED OF SMOKE AND BURN SMELL COMING FROM THE INFUSION PUMP. THE SYSTEM WAS REMOVED FROM ROOM AND BIOMED NOTIFIED IN THE MORNING. BIOMED HAS PUMPS, WE NOTICED THE TWO MODULES AFFECTED WERE ON THE LEFT SIDE. WE REMOVED THE MODULES AND SAW ON IUI CONNECTOR WAS BURNT, POSSIBLY FLUID CAME IN CONTACT. WE TOOK PICTURES, AND CONTACTED CAREFUSION AND SENT THE PC AND THE 2 PUMPS TO CAREFUSION.======================MANUFACTURER RESPONSE FOR IV INFUSION SYSTEM, ALARIS PC (PER SITE REPORTER).======================HAVE NOT HEARD A RESPONSE.======================MANUFACTURER RESPONSE FOR INFUSION PUMP MODULE, ALARIS PUMP MODULE (PER SITE REPORTER).======================NO RESPONSE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251876 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC 8015 *
    251877 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC 8100 *
    251936 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC 8100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *