BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 3983887 · Received June 23, 2014

    Report

    Report Number
    2183502-2014-00430
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Report Date
    June 20, 2014
    Manufacturer
    SMITHS MEDICAL INC.
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING EVALUATED; THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATED THE PUMP ALARMED "CHECK CLUTCH." NO PT INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366230 MEDFUSION 3500 SYRINGE INFUSION PUMP FRN - SYRINGE INFUSION PUMP FRN SMITHS MEDICAL INC. 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE