BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN PAINSMART IOD INFUSION PUMP

    MDR report key: 6037758 · Received October 18, 2016

    Report

    Report Number
    1722139-2016-00578
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    August 15, 2016
    Report Date
    August 15, 2016
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 40PSI BACK PRESSURE TEST. THE 40PSI 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 "WHILE PRIMING, PUMP FREE FLOWED BY ITSELF." THIS OCCURRED DURING PRIMING, PRIOR TO PATIENT USE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688093 CURLIN PAINSMART IOD INFUSION PUMP INFUSION PUMP FRN MOOG MEDICAL DEVICES GROUP 360-1300-E5L3 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1