BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 3221337 · Received July 1, 2013

    Report

    Report Number
    1722139-2013-02341
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 UNDER INFUSED AT 9.2 ML INSTEAD OF 9.5 ML DURING TESTING. RATE AND DOSAGE ARE 125 ML/HR AND 10 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297847 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICES GROUP 6000 CMS IOD

    Patients

    Seq Age Sex Outcome Treatment
    1