BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 3181767 · Received June 6, 2013

    Report

    Report Number
    1722139-2013-01852
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP PASSED VOLUMETRIC ACCURACY TESTS WITHIN +/-5%.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT PUMP DID NOT PASS THE FLOW TEST. IT WAS OFF BY -5.7%. RATE AND DOSAGE ARE 125 ML/HR AND 30 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252037 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICES GROUP 6000 CMS IOD

    Patients

    Seq Age Sex Outcome Treatment
    1