BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 3131634 · Received May 6, 2013

    Report

    Report Number
    1722139-2013-00805
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MOOG MED DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP FAILED VOLUMETRIC ACCURACY TESTS AND PUMP'S PREVENTATIVE MAINTENANCE DUE DATE WAS PASSED ON (B)(6) 2012. PUMP WAS CALIBRATED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT PUMP FAILS VOLUMETRIC ACCURACY TEST AT 9.23 ML. RATE AND DOSE ARE 125 ML/HR AND 10 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197902 CURLIN INFUSION IV PUMP FRN MOOG MED DEVICES GROUP 6000 PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1