BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION PUMP

    MDR report key: 3830180 · Received May 12, 2014

    Report

    Report Number
    1722139-2014-00111
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    August 28, 2011
    Report Date
    July 9, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    P981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NEW PUMP SOFTWARE WAS INSTALLED. REFERENCE RECALL NUMBER X-1870-2011.

    Description of Event or Problem · 1

    INVESTIGATION FOUND THAT PUMP HAD EXPERIENCED THE ERROR CODE 45 IN PUMP'S HISTORY LOG. EVENT DATES WERE (B)(6) 2011 AND (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283310 CURLIN INFUSION PUMP PUMP, INFUSION FRN MOOG MEDICAL DEVICES GROUP 6000 PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1