BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYVASO INHALATION SYSTEM

    MDR report key: 3202294 · Received July 1, 2013

    Report

    Report Number
    MW5030706
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 18, 2013
    Manufacturer
    UT GMBH
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CONSUMER THAT A (B)(6), FEMALE PT WITH CHRONIC PULMONARY HEART DISEASE, WHO INITIATED INHALED TYVASO (TREPROSTINIL) ON AN UNREPORTED DATE AT 54 MICROGRAMS (NINE BREATHS) FOUR TIMES PER DAY OUT OF THE BACK OF HER OPTINEB UNIT WHEN THE BATTERY WAS ATTACHED. ONE PUMP WAS NOT PRODUCING MEDICATION, AS THERE WAS NO MEDICATION IN THE CHAMBER TO INHALE. WHEN HER FATHER WENT TO USE THE BACK UP PUMP, AND PLUGGED IN THE BATTERY, SMOKE CAME OUT OF THE PUMP, AND IT SMELLED LIKE SOMETHING WAS BURNING. BUBBLING OF THE BAFFLE WAS REVIEWED WITH THE PT'S FATHER, AND MEDICATION WAS BEING PRODUCED. THE FATHER WAS CERTAIN THAT THE PUMP DID NOT WORK. CONSUMER REPORTER DETAILS WITHHELD, USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298943 TYVASO INHALATION SYSTEM NEBULIZER CAF UT GMBH ON-100/7

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other TYVASO