BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS INFUSION PUMP

    MDR report key: 1190485 · Received October 7, 2008

    Report

    Report Number
    1190485
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    August 24, 2008
    Report Date
    October 7, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ALARMS WERE GOING OFF ON BOTH PUMP MODULES. A COMMUNICATION ERROR WAS FLASHING ON BOTH MODULES. UNABLE TO CHANNEL OFF, BUT THE BRAIN OF THE PUMP WAS WORKING FINE. PUMPS CHANGED. NO PATIENT HARM. BIOMEDICAL ENGINEERING ASSESSMENT: BOTH MODULES HAD "CALL STACK DATA ERRORS" IN THE ALARM LOG. BOTH LVP MODULES WERE SENT TO CARDINAL HEALTH CUSTOMER ADVOCACY FOR ANALYSIS AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION PUMP PUMP, IV, MODULE FRN CARDINAL HEALTH 8100 *
    2 ALARIS INFUSION PUMP PUMP, IV, MODULE FRN CARDINAL HEALTH 8100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR