BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN 6000 CMS INFUSION PUMP

    MDR report key: 6036676 · Received October 18, 2016

    Report

    Report Number
    1722139-2016-00577
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    August 5, 2016
    Report Date
    August 9, 2016
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MMDG AND EVALUATED FOR THE FREE FLOW COMPLAINT. THE PUMP DID PASS VOLUMETRIC TESTING AS WELL AS 40 PSI BACK PRESSURE TEST. THE 40 PSI TEST IS THE TEST THAT CHECKS FOR FREE FLOW. MMDG WAS UNABLE TO REPLICATE THE FREE FLOW EVENT OR CONFIRM THE COMPLAINT. THE PUMP IS OPERATING WITHIN PRODUCT SPECIFICATIONS. THE PUMP WILL BE RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THAT THE PUMP "IMMEDIATELY DELIVERED 5 ML WITHOUT ANY BUTTONS BEING PUSHED" DURING SET UP. THE INITIAL REPORTER STATED THAT THE PUMP HAD NOT BEEN PLACED ON THE PATIENT WHEN THE EVENT OCCURRED, AND THAT THERE WAS NO ADVERSE EVENT OR DELAY IN THERAPY. [(B)(4)]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688277 CURLIN 6000 CMS INFUSION PUMP INFUSION PUMP FRN MOOG MEDICAL DEVICES GROUP 360-1400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1