BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, IV

    MDR report key: 1000962 · Received February 12, 2008

    Report

    Report Number
    1000962
    Event Type
    Malfunction
    Date Received
    February 12, 2008
    Date of Event
    November 12, 2007
    Report Date
    February 12, 2008
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ALL FOUR CHANNELS ALARMED "COMMUNICATION ERROR" OR "SYSTEM ERROR." THE NURSE TURNED THE UNIT OFF AND BACK ON AGAIN. THE PUMP WORKED; HOWEVER, IT DID NOT RETAIN THE PATIENT'S SETTINGS. THE BIOMEDICAL ASSESSMENT REVEALED THAT THE PCU ERROR LOG HAD EIGHT CODE 800.8000.0 ERRORS. THE ERRORS DID NOT REPEAT WHEN THE DEVICE WAS BENCH TESTED. THE PCU WILL BE SENT TO ALARIS FOR EVALUATION AND REPAIR. THERE WAS NO PATIENT HARM AS A RESULT OF THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP, IV ALARIS PC FRN ALARIS MEDICAL SYSTEMS, INC. 8015 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR