BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 811173 · Received January 22, 2007

    Report

    Report Number
    811173
    Event Type
    Malfunction
    Date Received
    January 22, 2007
    Date of Event
    January 18, 2007
    Report Date
    January 22, 2007
    Manufacturer
    CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PROBLEM: A PATIENT IN THE ICU WAS RECEIVING MEDICATION VIA THE INFUSION PUMPS WHEN THE PUMP CONTROLLER WENT INTO A "SYSTEM FAILURE" ALARM CONDITION. CORRECTIVE ACTION/RECOMMENDATION: ACCORDING TO THE MANUFACTURER, WHEN THE DEVICE GOES INTO AN ALARM CONDITION, THE PUMPS ARE DESIGNED TO CONTINUE PUMPING AT THE RATE LAST GIVEN TO THE PUMP. THE NURSES SAID THEY DID NOT CONTINUE PUMPING. THEY WERE REPLACED WITH ANOTHER COMPLETE SETUP. THE MALFUNCTIONING CONFIGURATION WAS SENT TO BIOMEDICAL ENGINEERING, AND LATER TO THE MANUFACTURER FOR AN IN-DEPTH ANALYSIS. THE BIOMED IN-HOUSE PRELIMINARY FINDINGS AFTER DOWNLOADING THE ERROR LOG REVEALED THE CONTROLLER DID HAVE A COMMUNICATIONS FAILURE. WE ARE WAITING FOR AN EQUIPMENT ANALYSIS REPORT FROM THE MANUFACTURER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP, IV FRN CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES 8015 *
    2 ALARIS MEDLEY MODULE, IV PUMP 1 FRN CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES 8100 *
    3 ALARIS MEDLEY MODULE, IV PUMP 2 FRN CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES 8100 *
    4 ALARIS MEDLEY MODULE, IV PUMP 3 FRN CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES 8100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *