BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 2961752 · Received January 16, 2013

    Report

    Report Number
    2183502-2012-00672
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 15, 2013
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. TESTING WAS ABLE TO REPRODUCE THE CUSTOMER'S COMPLAINT OF A "CHECK CLUTCH" ALARM. INSPECTION OF THE PUMP FOUND MISALIGNED CLUTCH HALVES. FOLLOWING REPLACEMENT OF THE CLUTCH HALVES, THE DEVICE WAS FOUND TO PASS ALL DELIVERY, ACCURACY AND FUNCTIONAL TESTING.

    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
    25163 MEDFUSION 3500 SYRINGE INFUSION PUMP SYRINGE INFUSION PUMP FRN SMITHS MEDICAL MD 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE