BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 3252573 · Received July 15, 2013

    Report

    Report Number
    1722139-2013-02660
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT THE PUMP'S VOLUMETRIC ACCURACY TESTS WERE NOT WITHIN +/-5%. THE PUMP WAS CALIBRATED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INFUSION WAS LOW DURING TESTING. THEY COULD NOT PROVIDE ANY FURTHER INFO SUCH AS RATE, DOSAGE, OR THE ALLEGED AMOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327542 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICES GROUP 4000 CMS

    Patients

    Seq Age Sex Outcome Treatment
    1