BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PUMP

    MDR report key: 4871998 · Received June 23, 2015

    Report

    Report Number
    4871998
    Event Type
    Other
    Date Received
    June 23, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 22, 2015
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PUMP CHANNEL STOPPED WHILE MEDICATION WAS INFUSING. (B)(4); MOD EEX4620. MOD "FAILED THE OCCLUSION TEST" PER CLINICAL ENGINEERING DEPARTMENT. EVENT UF/IMPORTER REPORT # 330140-2015-02 WAS SUBMITTED TO THE SAME COMPANY FOR MEDICATION INFUSION COMPLETELY INFUSED WITHIN ONE HOUR AND 20 MINUTES OF INITIATION OF INFUSION WITH SETTINGS VERIFIED BY TWO STAFF. (B)(4); MOD 8100; DATE OF EVENT: (B)(6) 2015; DATE OF REPORT: (B)(4) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404718 ALARIS PUMP FRN CAREFUSION CORP EEX4620

    Patients

    Seq Age Sex Outcome Treatment
    1 Other