BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 2854176 · Received November 28, 2012

    Report

    Report Number
    3004531588-2012-00013
    Event Type
    Injury
    Date Received
    November 28, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, A RESPIRATORY THERAPIST (RT) REPORTED THAT INOMAX DSIR DEVICE ((B)(4)) ALARMED "HIGH NO" WHILE IN USE ON A PATIENT ((B)(4)). INOMAX DSIR DEVICE ((B)(4)) IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF COMPLETION OF THE INVESTIGATION. DURING THE SITES OWN INTERNAL INVESTIGATION, IT WAS DETERMINED BY A PULMONARY INTENSIVIST THAT THERE WERE NO CHANGES IN THE PA PRESSURES DURING THE "HIGH NO" ALARM AND THEREFORE, "THE NITRIC WOULD NOT BE THE CAUSE" FOR THE PATIENT TO GO INTO ASYSTOLE DURING THE ALARM. THE INTENSIVIST ALSO BELIEVES THAT THE ATTEMPT TO TURN THE PATIENT TO BE CLEANED IS WHAT LED THE PATIENT TO GO INTO ASYSTOLE AT 09:53 ON (B)(6) 2012 AND SUBSEQUENTLY DIE; THERAPY WITH INO OR THE INOMAX DEVICE REPORTEDLY HAD NOTHING TO DO WITH THIS EVENT. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. COMPANY COMMENT DATED (B)(4) 2012: THIS (B)(6) PATIENT STATUS POST CARDIAC SURGERY EXPERIENCED 3 INSTANCES OF CARDIAC ARREST WHILE RECEIVING INO THERAPY; THE PATIENT ULTIMATELY SUCCUMBED TO THE FINAL ARREST. THE INITIAL CODE APPEARS TO HAVE BEEN DUE TO A PREMATURE ATTEMPT TO WEAN THIS UNSTABLE PATIENT FROM INO THERAPY. WHILE THE SECOND ARREST CANNOT BE EXCLUDED AS HAVING BEEN RELATED TO THE INTERRUPTION OF THERAPY THAT OCCURRED AFTER A POTENTIAL DEVICE MALFUNCTION, THE PULMONOLOGIST WHO REVIEWED THE CASE JUDGED THE TWO EVENTS TO BE UNRELATED BECAUSE OF A REPORTED LACK OF EVIDENCE FOR REBOUND PULMONARY HYPERTENSION (PULMONARY ARTERY PRESSURES WERE REPORTEDLY STABLE DURING THE EVENT). THE FATAL ARREST APPEARS TO HAVE NO POTENTIAL RELATIONSHIP WITH INO THERAPY AS THERE WAS NO CONCURRENT DEVICE MALFUNCTION, NO INTERRUPTION OF INO THERAPY, AND THEREFORE NO POTENTIAL FOR CARDIOVASCULAR COLLAPSE DUE TO WITHDRAWAL OF THERAPY.

    Description of Event or Problem · 1

    HIGH NO ALARM (DEVICE ISSUE). CODED (CARDIAC ARREST). CASE DESCRIPTION: THIS INITIAL SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012, FROM A RESPIRATORY THERAPIST (RT) TRAINING EDUCATOR IN THE UNITED STATES VIA THE (B)(6). SHE CALLED TO REPORT THAT INOMAX DSIR DEVICE ((B)(4)) ALARMED "HIGH NO" WHILE IN USE ON A PATIENT AND HE SUBSEQUENTLY "CODED" BUT WAS LATER RESUSCITATED. FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2012, WAS PROVIDED BY THE RT TRAINING EDUCATOR, WITH ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012, PROVIDED BY THE RT MANAGER ALSO PROCESSED WITH THE INITIAL. THE PATIENT WAS A (B)(6) MALE STATUS-POST (S/P) CARDIAC VALVE REPLACEMENT WHO WAS PLACED ON A CONVENTIONAL ASSIST/CONTROL VENTILATOR AT A FRACTION INSPIRED OXYGEN (FIO2) OF 90% (DATE AND TIME NOS) AND WAS INITIATED ON INO THERAPY AT 40 PARTS PER MILLION (PPM) (DATE AND TIME NOS). ON THE NIGHT OF (B)(6) 2012, AN ATTEMPT WAS MADE TO WEAN THE PATIENT DOWN FROM 40 TO 10 TO 5 PPM OF INO AND TO START HIM ON EPOPROSTENOL, AND SUBSEQUENTLY, HE WENT INTO CARDIAC ARREST. AT THIS TIME, CHEST COMPRESSIONS WERE ADMINISTERED AND HE WAS SUCCESSFULLY RESUSCITATED; THE PATIENT WAS RESTARTED ON INO THERAPY AT 40 PPM. THE RT TRAINING INSTRUCTOR REPORTED THAT ON (B)(6) 2012 IN THE MORNING (EXACT TIME NOT REPORTED), THE INOMAX DSIR DEVICE ((B)(4)) ALARMED AND WHEN SHE GOT TO THE BEDSIDE, THE SCREEN ON THE DEVICE READ "HIGH NO" AND THE NO LEVEL READ 160 PPM, CAUSING THE DELIVERY SHUT DOWN ALARM. DURING THIS TIME, THE PATIENT REPORTEDLY CODED (WENT INTO ASYSTOLE). SHE BAGGED THE PATIENT USING THE INOBLENDER "RIGHT AWAY" AND A NEW DEVICE WAS PUT INTO PLACE "IMMEDIATELY" AND WAS SET AT 40 PPM. IN ADDITION, CHEST COMPRESSIONS WERE BEGUN AND EPINEPHRINE WAS GIVE; THE PATIENT WAS SUCCESSFULLY RESUSCITATED AND CONTINUED TO RECEIVE INO THERAPY AT 40 PPM VIA A NEW DSIR DEVICE. AT 09:53 ON (B)(6) 2012, THE PATIENT WAS BEING TURNED TO BE CLEANED, HE REPORTEDLY BECAME HEMODYNAMICALLY UNSTABLE AND WENT INTO CARDIAC ARREST AGAIN. AT THIS TIME THERE WAS NO DEVICE ISSUE AND THE PATIENT WAS RECEIVING INO THERAPY AT 40 PPM. EVEN THOUGH CHEST COMPRESSIONS WERE ATTEMPTED ALONG WITH OTHER CARDIAC RESUSCITATION MEASURES, THE PATIENT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening