BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 2922749 · Received December 28, 2012

    Report

    Report Number
    1722139-2012-01235
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP FAILS VOLUMETRIC ACCURACY TESTS. PUMP WAS CALIBRATED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT PUMP FAILS VOLUMETRIC ACCURACY TESTS. TESTS WERE RAN FOR FOUR TIMES WITH READINGS OF TWO TIMES OF 10.6 ML AND TWO TIMES OF 10.70 ML. RATE AND DOSE ARE 125 ML/HR AND 10 ML.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1