BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 3173087 · Received May 30, 2013

    Report

    Report Number
    1722139-2013-01527
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MOOG MEDICAL DEVICE GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT PUMP DELIVERED UNDER DURING TESTING. THE RESULTS WERE 8.777 AND 8.775 ML AT RATE OF 125 ML/HR AND DOSAGE WAS 10 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239921 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICE GROUP 6000 PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1