BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 2343340 · Received November 16, 2011

    Report

    Report Number
    3004531588-2011-00043
    Event Type
    Injury
    Date Received
    November 16, 2011
    Date of Event
    October 17, 2011
    Report Date
    November 16, 2011
    Manufacturer
    INO THERAPEUTICS LLC.IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, A RESPIRATORY CARE PROFESSIONAL (RCP) REPORTED ((B)(4)) THAT INOMAX DS DEVICE, (B)(4), ALARMED A MONITORING FAILURE WHILE IN USE ON A PATIENT. INOMAX DS DEVICE, (B)(4) IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A RESPIRATORY CARE PROFESSIONAL (RCP) REPORTED THAT INOMAX DS DEVICE, (B)(4), ALARMED A MONITORING FAILURE WHILE IN USE ON A PATIENT. ON (B)(6) 2011, AN ADULT MALE, WHILE UNDERGOING A CARDIAC ARTERY BYPASS GRAFT (CABG), WAS STARTED ON INOMAX AT 40 PPM VIA INOMAX DS DEVICE (B)(4) FOR ELEVATED PULMONARY ARTERY PRESSURE AND RIGHT HEART FAILURE. FOLLOWING THE SURGERY, THE PATIENT CONTINUED TO RECEIVE INOMAX AT 40 PPM AND WAS NOTED TO HAVE AN OXYGEN SATURATION OF 98% ON PB840 VENTILATOR WITH FRACTION OF INSPIRED OXYGEN (FIO2) 0.5. AT 22:49, THE INOMAX DS DEVICE (B)(4) ALARMED A MONITORING FAILURE. THE BEDSIDE RCP INITIALLY THOUGHT THAT THE DEVICE WAS STILL DELIVERING NITRIC OXIDE AND STARTED TO JUST CHECK THE CONNECTIONS AND AT APPROXIMATELY 22:50, THE PATIENT'S MEAN ARTERIAL PRESSURE (MAP) HAD DECREASED TO 62 (84 AT 20:50). AT 22:55 PULMONARY ARTERY PRESSURE (PAP) BEGAN TO INCREASE TO THE 60S (49/25 AT 20:50), CARDIAC INDEX (CI) DECREASED TO 1.4 (2.5 AT 20:50), CARDIAC INDEX (CI) DECREASED TO 1.4 (2.5 AT 20:50), CVP (CARDIAC WEDGE PRESSURE PER RCP) INCREASED TO 18 (10 AT 20:50), AND THE RESPIRATORY THERAPIST BEGAN TO MANUALLY VENTILATE THE PATIENT VIA THE INOBLENDER WITH 100% OXYGEN AND NITRIC OXIDE DOSE SET AT 40 PPM. WHILE BEING MANUALLY VENTILATED, THE PATIENT WAS SWITCHED TO ANOTHER INOMAX DS DEVICE AND WAS THEN RETURNED TO THE VENTILATOR. A FEW MINUTES LATER, IT WAS NOTED THAT THE PATIENT'S VITAL SIGNS RETURNED TO NORMAL, THE RCP ESTIMATED 20 MINUTES ELAPSED FROM THE TIME THE DEVICE ALARMED UNTIL THE PATIENT'S VITAL SIGNS RETURNED TO BASELINE. AT 23:15 PAP WAS 45/22, MAP WAS 84, CI WAS 2.1 AND CVP WAS 12. THE RESPIRATORY THERAPIST CONSIDERED EVENTS TO BE PROBABLY RELATED TO THE DEVICE MALFUNCTION. THE DEVICE HAS BEEN RETURNED TO THE COMPANY FOR FURTHER INVESTIGATION. THE COMPANY CONSIDERED THE REPORTED EVENT OF INCREASED PULMONARY ARTERIAL PRESSURE (WITH THE ASSOCIATED DECREASE IN CARDIAC INDEX, INCREASE IN CENTRAL VENOUS PRESSURE, AND DECREASE IN MEAN ARTERIAL PRESSURE) TO BE MEDICALLY SIGNIFICANT AND THEREFORE A SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOMAX DS (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC.IKARIA 10003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other