BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION 6000CMS IOD IV PUMP

    MDR report key: 2228500 · Received August 23, 2011

    Report

    Report Number
    1722139-2011-00219
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Removal / Correction Number
    Z-1868-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ERROR CODE 45 WAS FOUND IN THE PUMP HISTORY LOG. THE PUMP SOFTWARE WAS UPGRADED. SERIAL NUMBER 220641 IS PART OF RECALL NUMBER Z-1868-2011.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES PUMP EXPERIENCED ERROR CODE 45.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1