BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOVENT (DELIVERY SYSTEM)

    MDR report key: 1884970 · Received October 22, 2010

    Report

    Report Number
    2112667-2010-00049
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 22, 2010
    Manufacturer
    DATEX-OHMEDA
    Product Code
    MRN
    PMA / PMN Number
    K000186
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INOMAX WAS DELIVERED VIA INOVENT (B)(4) THROUGH THE VAPOTHERM (HUMIDIFICATION SYSTEM) SET AT 25 LITERS/MINUTE INTO A NASAL CANNULA. ON THE SECOND DAY OF TREATMENT ON (B)(6) 2010, THE INOVENT DEVICE HAD "DASHES ON THE SCREEN AND THE DRAIN BOTTLE KEPT POPPING OFF." METHODS: DEVICE NOT RETURNED. TECHNICAL SUPPORT RESOLVED DEVICE MISUSE ISSUE VIA PHONE. EVALUATION SUMMARY PAGE: THE DEVICE SUMMARY IS AS FOLLOWS: THE ROOT CAUSE IS USER ERROR. THE VAPOTHERM HUMIDIFICATION SYSTEM IS NOT VALIDATED WITH THE USE OF THE INOVENT DEVICE. (B)(6) TECHNICAL SUPPORT INFORMED THE RESPIRATORY THERAPIST ABOUT THE ISSUES RELATED TO THE USE OF THE VAPOTHERM WITH THE INOVENT. THE REPORTED INOVENT ISSUES RESOLVED AND THE INOVENT FUNCTIONED NORMALLY WHEN THE PT WAS REMOVED FROM THE VAPOTHERM DEVICE AND PLACED ON A STANDARD NASAL CANNULA. THE INOVENT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A (B)(6) FEMALE CARDIAC PT RECEIVED 40 PARTS PER MILLION (PPM) OF INOMAX FOR THE TREATMENT OF MITRAL STENOSIS FOR APPROXIMATELY 3 TO 5 DAYS. INOMAX WAS DELIVERED VIA INOVENT (B)(4) THROUGH THE VAPOTHERM (HUMIDIFICATION SYSTEM) SET AT 25 LITERS/MINUTE INTO A NASAL CANNULA. ON THE SECOND DAY OF TREATMENT ON (B)(6) 2010, THE INOVENT DEVICE HAD "DASHES ON THE SCREEN AND THE DRAIN BOTTLE KEPT POPPING OFF. (B)(6) TECHNICAL SUPPORT INFORMED THE RESPIRATORY THERAPIST THAT VAPOTHERM IS NOT VALIDATED FOR USE WITH THE INOVENT AND DISCUSSED THE POTENTIAL RELATED ISSUES. THE CUSTOMER DECREASED THE OXYGEN FLOW TO 20 LITERS/MINUTE WHICH STOPPED THE DRAIN BOTTLE FROM POPPING OFF. THE DRAIN BOTTLE CAN BECOME DISLODGED WHEN THE SAMPLE LINE IS OVER PRESSURIZED WITH HIGH FLOW RATES. THE RESPIRATORY THERAPIST WAS SATISFIED WITH THE CURRENT DELIVERY, BUT WAS INFORMED BY (B)(6) TECHNICAL SUPPORT THAT SHE MAY ENCOUNTER PROBLEMS WITH CONTINUED USE ON 20 LITES/MINUTE. THE INOVENT DEVICE LATER DISPLAYED A SERVICE ADVISORY ALARM AND THE RESPIRATORY THERAPIST WAS AGAIN ADVISED BY (B)(6) TECHNICAL SUPPORT ABOUT THE ISSUES RELATED TO USE OF THE INOVENT WITH THE VAPOTHERM. A SERVICE ADVISORY CAN RESULT WHEN THE INOVENT IS USED WITH THE VAPOTHERM. THE ANESTHESIOLOGIST REPORTS THE PT EXPERIENCED PULMONARY PRESSURE INCREASE OF 15-20 MMHG, PULMONARY EDEMA, AND SHORTNESS OF BREATH DURING THIS TIME. THE ANESTHESIOLOGIST REPORTS THE PT WAS DISCONTINUED OFF. THE ANESTHESIOLOGIST REPORTS THE PT WAS DISCONTINUED OFF THE VAPOTHERM AND PUT BACK ON NASAL CANNULA ALONE. THE PULMONARY PRESSURE INCREASE, PULMONARY EDEMA, AND SHORTNESS OF BREATH RESOLVED AND THE ANESTHESIOLOGIST DEEMS THE EVENTS MODERATE IN SEVERITY AND NON-SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOVENT (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN DATEX-OHMEDA 1605-9200-000

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other