BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1884969 · Received October 22, 2010

    Report

    Report Number
    3004531588-2010-00108
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    INO THERAPEUTICS LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), 2010, A RESPIRATORY THERAPIST REPORTED DELIVERY FAILURE ON AN INOMAX DS #(B)(4). THE RESPIRATORY THERAPIST FELT THAT THE SAMPLE T WAS TOO CLOSE TO THE WYE "Y" ON THE PT'S BREATHING CIRCUIT. HE SUBSEQUENTLY CLAMPED THE ENDOTRACHEAL TUBE AND MOVED THE SAMPLE T FURTHER AWAY FROM THE Y. THE PT'S BREATHING CIRCUIT WAS UNCLAMPED AND THE PT'S DOSE OF INOMAX WAS INCREASED FROM 60 PPM TO 80 PPM. DELIVERY FAILURE OCCURRED WHEN ATTEMPTING TO INCREASE THE PT TO 80 PARTS PER MILLION (PPM). EVALUATION SUMMARY PAGE. THE DEVICE FUNCTIONED PROPERLY DURING INVESTIGATIONAL TESTING, WHICH INCLUDED FUNCTIONAL TESTING AND CHECKOUT. DELIVERY FAILURE COULD NOT BE REPRODUCED AND WAS LIKELY CAUSED BY A SPIKE IN FLOW THROUGH INJECTOR MODULE PEAKING AT 120 1PM. WHILE TRYING TO DELIVER 80PPM OF NITRIC OXIDE, WHICH IS OUTSIDE DEVICE SPECIFICATIONS. THE ROOT CAUSE FOR THIS INCIDENT WAS USER ERROR AS THE UNDER-DELIVERY APPEARS TO BE RELATED TO THE OPERATION OF THE DEVICE OUTSIDE OF DESIGN SPECIFICATIONS.

    Description of Event or Problem · 1

    AN ADULT PT IN THE CARDIAC UNIT WAS INTUBATED ON VERY HIGH VENTILATOR SUPPORT WITH A POSITIVE-END EXPIRATORY PRESSURE (PEEP) OF 10. THE PT WAS TREATED WITH 60 PARTS PER MILLION (PPM) OF INOMAX FOR AN UNK INDICATION. THE RESPIRATORY THERAPIST IDENTIFIED THAT THE SAMPLE T WAS TOO CLOSE TO THE WYE "Y" ON THE PT'S BREATHING CIRCUIT. HE SUBSEQUENTLY CLAMPED THE ENDOTRACHEAL TUBE AND MOVED THE SAMPLE T FURTHER AWAY FROM THE Y. THE PT'S BREATHING CIRCUIT WAS UNCLAMPED AND THE PT'S DOSE OF INOMAX WAS INCREASED FROM 60 PPM TO 80 PPM. THE INOMAX DS DEVICE REGISTERED A DELIVERY FAILURE. THE CYLINDER WAS NOT EMPTY. THE PT WAS MANUALLY VENTILATED WITH THE INOBLENDER WHILE THE INOMAX DS DEVICE WAS SWAPPED FOR ANOTHER DEVICE. DURING MANUAL VENTILATION, THE PT WENT INTO CARDIAC ARREST. THE PT WAS SUCCESSFULLY RESUSCITATED AND THE ARREST RESOLVED. THE PT WAS PLACED ON A NEW DEVICE AND STABILIZED. THE RESPIRATORY THERAPIST DEEMS THE EVENT OF CARDIAC ARREST AS DEFINITELY RELATED TO AN INTERRUPTION IN INO THERAPY RELATED TO THE DEVICE FAILURE WITH THE INOMAX DS DEVICE. THE PHYSICIAN DEEMS THE LOSS OF NITRIC OXIDE (NO) A DIRECT CAUSE OF THE CARDIAC ARREST DUE TO CONSTRICTED LOAD ON THE PT'S WEAK HEART. THE INOMAX DEVICE IS NOW WITH HOSPITAL RISK MANAGEMENT AND AN ON-SITE INSPECTION BY (B)(4) HAS BEEN REQUESTED BY RISK MANAGEMENT.

    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 Life Threatening