BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN 4000CMS IV PUMP

    MDR report key: 2943587 · Received January 9, 2013

    Report

    Report Number
    1722139-2013-00017
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    January 1, 2009
    Report Date
    January 7, 2009
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING OF THE PUMP INDICATES IT WAS ABOVE VOLUMETRIC ACCURACY TEST PARAMETERS. PUMP WAS CALIBRATED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    PM DUE, VOLUMETRIC INFUSION WAS HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11453 CURLIN 4000CMS IV PUMP FRN MOOG MEDICAL DEVICES GROUP CURLIN 4000CMS

    Patients

    Seq Age Sex Outcome Treatment
    1