BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 6125418 · Received November 23, 2016

    Report

    Report Number
    3006803715-2016-00187
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 27, 2016
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020082
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP EVALUATION INCLUDED VISUAL INSPECTION, PRIMING THE CATHETER ACCESS PORT, PROGRAMMING A BOLUS FLOW RATE, AND PERFORMING RELEVANT FLOW RATE TESTS. THE PUMP PRIMED AND OPERATED PER SPECIFICATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED ISSUE WAS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP STOPPED WORKING, AND THAT THE PATIENT WAS NOT RECEIVING PUMP THERAPY. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775404 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827 00810335020082

    Patients

    Seq Age Sex Outcome Treatment
    1