BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 3933746 · Received April 2, 2014

    Report

    Report Number
    1722139-2014-00078
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    September 13, 2007
    Report Date
    March 25, 2014
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Removal / Correction Number
    Z-1870-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NEW PUMP SOFTWARE WAS INSTALLED. REFERENCE RECALL NUMBER Z-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 ARE (B)(6) 2007, (B)(6) 2008, (B)(6) 2009, (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196927 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICES GROUP 6000 PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1