BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 4113695 · Received September 17, 2014

    Report

    Report Number
    3006803715-2014-00026
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    FLOWONIX MEDICAL INC.
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    DURING A REFILL VISIT, THE NURSE REPORTED THAT SHE WAS HAVING DIFFICULTY PROGRAMMING THE PATIENT'S PUMP. THE PUMP WAS GIVING ERROR CODES WHEN INQUIRED. THE NURSE REFILLED THE PATIENT'S PUMP AND THEN STOPPED THE PUMP BY PERFORMING AN EMERGENCY PUMP STOP. AFTER THE PUMP WAS STOPPED, THE REFILL WAS PROGRAMMED AND THE PUMP WAS SET TO A CONSTANT FLOW. DURING THE ATTEMPT TO PROGRAM THE CONSTANT FLOW, THE PROGRAMMER RETURNED AN ERROR MESSAGE. THE NURSE HAD REPORTED THAT PATIENT HAD A LACK OF THERAPY. IT WAS ALSO REPORTED THAT THE PATIENT MAY HAVE FALLEN RECENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575724 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL INC. 11827

    Patients

    Seq Age Sex Outcome Treatment
    1