BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 3171834 · Received May 23, 2013

    Report

    Report Number
    1722139-2013-01262
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MOOG MEDICAL DEVICES 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 PUMP FAILED VOLUMETRIC ACCURACY TESTS. PUMP WAS CALIBRATED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATED THAT PUMP FAILS VOLUMETRIC ACCURACY TEST AT 9.52ML (RATE AND DOSAGE ARE 125ML/HR AND 10ML) AND 4.59ML (RATE AND DOSAGE ARE 19.9ML/HR AND 5ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228092 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICES GROUP 6000 PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1