BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 3063078 · Received February 18, 2013

    Report

    Report Number
    2183502-2013-00034
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 15, 2013
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. TESTING INDICATED THAT THE POSITION POTENTIOMETER WAS CONTAMINATED, WHICH CAUSED THE PUMP TO ALARM CHECK CLUTCH/PLUNGER ALARM. THE POSITION POTENTIOMETER WAS REPLACED. FOLLOWING REPAIR, THE DEVICE PASSED ALL FUNCTION AND DELIVERY TESTING.

    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
    72206 MEDFUSION 3500 SYRINGE INFUSION PUMP SYRINGE INFUSION PUMP FRN SMITHS MEDICAL MD 3500 M78354

    Patients

    Seq Age Sex Outcome Treatment
    1