BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 1760643 · Received July 12, 2010

    Report

    Report Number
    2183502-2010-00286
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 11, 2010
    Report Date
    July 11, 2010
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE REPORTER STATED, AN INFUSION SCHEDULED FOR 6 HOURS WAS COMPLETED IN 60 MINUTES. THE REPORTER STATED THERE WAS NO ADVERSE EFFECT ON THE PT AND NO ADDITIONAL MEDICAL INTERVENTION WAS TAKEN.

    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