BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PATIENT THERAPY CONTROLLER

    MDR report key: 6179315 · Received December 15, 2016

    Report

    Report Number
    3006803715-2016-00199
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 17, 2016
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020174
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS SUBJECTED TO EXTERNAL AND INTERNAL VISUAL INSPECTION, AS WELL AS ELECTRICAL AND FUNCTIONAL TESTING. THE EVALUATION DETERMINED THAT THE ISSUE WAS CAUSED BY A POWER BUTTON RIBBON CABLE THAT WAS NOT CONNECTED PROPERLY. MANUFACTURING PROCESS TEST RESULTS CONFIRM THAT THE CABLE WAS CONNECTED PRIOR TO DEVICE SHIPMENT. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENT WAS CONFIRMED. CORRECTED G8 PER REQUEST OF FDA, DATED 10/SEP/2020. INTERNAL COMPLAINT NUMBER: (B)(4).

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) WOULD NOT TURN ON. THERE WERE NO PATIENT EFFECTS REPORTED, AND THE DEVICE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829382 PROMETRA PATIENT THERAPY CONTROLLER INFUSION PUMP PROGRAMMER LKK FLOWONIX MEDICAL, INC 12860 00810335020174

    Patients

    Seq Age Sex Outcome Treatment
    1