BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3500

    MDR report key: 1901016 · Received October 18, 2010

    Report

    Report Number
    1901016
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 18, 2010
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PUMP SET FOR CERTAIN VOLUME LIMIT. DID NOT ALARM OR STOP AT VOLUME LIMIT. KEPT INFUSING. STOPPED INFUSION AND REMOVED PUMP.====================== HEALTH PROFESSIONAL'S IMPRESSION======================NOT APPLICABLE====================== MANUFACTURER RESPONSE FOR INFUSION PUMP, SYRINGE, INFUSION PUMP, SYRINGE======================AWAITING RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3500 INFUSION PUMP, SYRINGE FRN SMITHS MEDICAL 3500 NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO