BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 5001792 · Received August 13, 2015

    Report

    Report Number
    3006803715-2015-00051
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 14, 2015
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    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 SUMMARY: THE PUMP INVESTIGATION INCLUDED PRIMING THE CATHETER ACCESS PORT, PROGRAMMING A BOLUS FLOW RATE, AND PERFORMING RELEVANT FLOW RATE TESTS. THE PUMP PRIMED AND FLOWED PER SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, THE REPORTED EVENT COULD NOT BE CONFIRMED. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO RESERVOIR VOLUMES HIGHER THAN EXPECTED IN THE PUMP WERE OBSERVED ON (B)(6) 2015 AND (B)(6) 2015. THE PUMP WAS EXPLANTED ON (B)(6) 2015 AND WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533672 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827

    Patients

    Seq Age Sex Outcome Treatment
    1