BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PATIENT THERAPY CONTROLLER

    MDR report key: 6039655 · Received October 19, 2016

    Report

    Report Number
    3006803715-2016-00161
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 29, 2016
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020174
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING EVALUATED AT THE MANUFACTURING SITE. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS SUBJECTED TO VISUAL EXTERNAL AND INTERNAL INSPECTION, AS WELL AS FUNCTIONAL TESTING. THE EVALUATION DETERMINED THAT THE ISSUE WAS DUE TO A COMPONENT THAT 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 THERAPY CONTROLLER (PTC) BECAME UNRESPONSIVE. TROUBLESHOOTING ATTEMPTS WERE NOT SUCCESSFUL. THERE WERE NO PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691139 PROMETRA PATIENT THERAPY CONTROLLER INFUSION PUMP PROGRAMMER LKK FLOWONIX MEDICAL, INC 12860 00810335020174

    Patients

    Seq Age Sex Outcome Treatment
    1