BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 3944286 · Received May 8, 2014

    Report

    Report Number
    2183502-2014-00275
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. THE ACTUAL DEVICE INVOLVED WAS RETURNED AND IS CURRENTLY UNDER EVALUATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278017 MEDFUSION 3500 SYRINGE INFUSION PUMP FRN - SYRINGE INFUSION PUMP FRN SMITHS MEDICAL 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE