BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION PLUS

    MDR report key: 775522 · Received October 10, 2006

    Report

    Report Number
    775522
    Event Type
    Malfunction
    Date Received
    October 10, 2006
    Date of Event
    September 22, 2006
    Report Date
    October 10, 2006
    Manufacturer
    RYMED TECHNOLOGIES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    PT. PRESSURES INCREASED BOTH ON VENTILATOR AND PULMONARY ARTERY PRESSURES. RN FOUND RYMED INVISION PLUS NEUTRAL IV CONNECTOR HAD DISASSEMBLED. AS A RESULT, PT WAS NOT RECEIVING SEDATION OR PAIN MEDICINE THROUGH THE LINE AND BLOOD HAD BACKED UP AND WAS SLOWLY BLEEDING FROM THE END OF THE GREEN PORTION OF THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISION PLUS CONNECTOR, IV FPA RYMED TECHNOLOGIES, INC. RYM-5000 410

    Patients

    Seq Age Sex Outcome Treatment
    1 *