BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 4956551 · Received July 31, 2015

    Report

    Report Number
    3006803715-2015-00050
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 2, 2015
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MDR WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS SUBJECTED TO VISUAL EXTERNAL AND INTERNAL INSPECTION, AS WELL AS ELECTRICAL TESTING. THE EVALUATION DETERMINED THAT A COMPONENT WAS NOT OPERATING NORMALLY. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENT WAS CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE LACK OF PAIN RELIEF. WHEN THE PUMP WAS INQUIRED DURING A REFILL APPOINTMENT, THE PROGRAMMER DISPLAYED AN ERROR MESSAGE. THE PUMP WAS EXPLANTED AND REPLACED WITH A NEW PUMP ON (B)(6) 2015 AND WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501879 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827

    Patients

    Seq Age Sex Outcome Treatment
    1