BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 1841297 · Received September 16, 2010

    Report

    Report Number
    2183502-2010-00398
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 10, 2010
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER 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 PATIENT INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE