BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOFLO FILTER PORT

    MDR report key: 2030437 · Received February 12, 2010

    Report

    Report Number
    2247040-2010-00001
    Event Type
    Injury
    Date Received
    February 12, 2010
    Date of Event
    October 24, 2009
    Report Date
    February 12, 2010
    Manufacturer
    PHARMA SYSTEMS
    Product Code
    BYD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED INCREASED WORK BREATHING, RESPIRATORY RATE IN 20'S, PT WENT INTO A BRIEF RUN OF V-TACH, THEN RETURNED TO NORMAL SINUS. PT WAS BAGGED DURING THE EPISODE AND WHEN PLACED BACK ON THE VENT. THE HEAT MOISTURE EXCHANGER (HME) WAS NOTED TO BE WET. THE PT HAD BREATHING PROBLEMS AGAIN. THE HME WAS REPLACED WITH A NEW ONE AND THE PT IMMEDIATELY IMPROVED AND WAS COMFORTABLE. THE DEVICE DID NOT MALFUNCTION. THE DEVICE WAS WET WITH INCREASED RESISTANCE TO FLOW. DEVICE DOES NOT PRODUCE WATER/LIQUIDS. THE WATER OR SECRETIONS MUST HAVE COME FROM THE LAVAGING SOLUTION OR NEBULIZED MEDICATION OR EXCESS PT SECRETIONS. FLUID WAS INSERTED INTO THE AIRWAY WITH THE DEVICE STILL IN-LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOFLO FILTER PORT HEAT MOISTURE EXCHANGER BYD PHARMA SYSTEMS 6020A 090527-50

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention