BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 4938725 · Received July 24, 2015

    Report

    Report Number
    3006803715-2015-00048
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    May 11, 2015
    Report Date
    June 25, 2015
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN THE DEVICE IS RETURNED AND THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MDR WILL BE FILED. INTERNAL COMPLAINT NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION:THE RETURNED PUMP WAS SUBJECTED TO EXTERNAL AND INTERNAL EXAMINATIONS, AS WELL AS, FUNCTIONAL, FLOW, AND ELECTRONICS TESTING. THE EVALUATION DETERMINED THAT A COMPONENT WAS NOT OPERATING NORMALLY. BASED ON THE INVESTIGATION, THE REPORTED EVENT WAS CONFIRMED.(B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING INVESTIGATED AT THE MANUFACTURING SITE. WHEN THE INVESTIGATION IS COMPLETE, ANOTHER SUPPLEMENTAL MDR WILL BE FILED.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE LACK OF PAIN RELIEF. A RESERVOIR VOLUME HIGHER THAN EXPECTED IN THE PUMP WAS OBSERVED. A CATHETER ACCESS PORT (CAP) PROCEDURE WAS PERFORMED AND FOUND THAT THE CATHETER WAS PATENT. THE PUMP WAS REFILLED AND THE PUMP THERAPY WAS CONTINUED. ON (B)(6) 2015, ANOTHER RESERVOIR VOLUME HIGHER THAN EXPECTED IN THE PUMP WAS OBSERVED. IT WAS DETERMINED THAT THE PUMP WILL BE EXPLANTED AND RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2015. THE PUMP WAS EXPLANTED AND RETURNED FOR EVALUATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2015 IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484043 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization