BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 2943739 · Received January 28, 2013

    Report

    Report Number
    2943739
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 28, 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

    UNIT FAILED ON PATIENT BY SHUTTING ITSELF OFF. PATIENT WAS ALREADY UNSTABLE BUT DROPPED HIS BP MORE. IV DRIPS WERE IMMEDIATELY TRANSFERRED TO ANOTHER PUMP. DRUGS INFUSING WERE DOPAMINE AND VERSED. DEFECTIVE PUMPS WERE REMOVED FROM SERVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?DRUGS INFUSING WERE DOPAMINE AND VERSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38121 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR COMBINATION OF LVP (LARGE VOLUME PUMP) MODULES AND| MAIN PCU (POINT OF CARE UNIT)