BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 3191105 · Received June 14, 2013

    Report

    Report Number
    1722139-2013-01977
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MOOG MEDICAL DEVICE GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT PUMP DID NOT PASS FLOW ACCURACY TEST. IT WAS UNDER 6.2% WHEN TESTED AT RATE 125 ML/HR AND DOSAGE WAS 30 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272203 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICE GROUP 4000 CMS

    Patients

    Seq Age Sex Outcome Treatment
    1