BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 3830206 · Received May 12, 2014

    Report

    Report Number
    1722139-2014-00112
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    May 24, 2013
    Report Date
    May 8, 2014
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NEW PUMP SOFTWARE INSTALLED. REFERENCE RECALL NUMBER X-1869-2011.

    Description of Event or Problem · 1

    INVESTIGATION FOUND THAT PUMP HAD EXPERIENCED THE ERROR CODE 45 IN PUMP'S HISTORY LOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283317 CURLIN INFUSION IV PUMP PUMP, INFUSION FRN MOOG MEDICAL DEVICES GROUP 6000 PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1