BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 6107399 · Received November 16, 2016

    Report

    Report Number
    3006803715-2016-00180
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 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 A PUMP RESERVOIR VOLUME HIGHER THAN EXPECTED WAS OBSERVED, AND THE DEVICE WAS LATER EXPLANTED. THERE WERE NO PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    THE PATIENT IS CURRENTLY DOING WELL. PUMP THERAPY WAS INTENDED TO TREAT BACK PAIN WITH MORPHINE AT A DOSAGE OF 0.3200 MG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757269 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 13827 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1