BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 2387543 · Received December 20, 2011

    Report

    Report Number
    3004531588-2011-00048
    Event Type
    Injury
    Date Received
    December 20, 2011
    Date of Event
    November 26, 2011
    Report Date
    December 20, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EVALUATION SUMMARY: THE DEVICE INVESTIGATION IS COMPLETE AND RESULTS FOLLOW: THE ROOT CAUSE IS A SYSTEM ERROR CAUSED BY A SEGMENTATION FAULT. THIS IS RELATED TO FIRMWARE RESIDENT ON A CPLD. THIS ROOT CAUSE WAS DETERMINED BY EXAMINATION OF THE SERVICE LOG. THE DEVICE FUNCTIONED AS DESIGNED TO INTERRUPT NITRIC OXIDE DELIVERY AND ALARM WHEN SUCH AN ERROR IS DETECTED. THE MAIN CIRCUIT BOARD WAS REPLACED AND THE DEVICE FUNCTIONED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THIS INITIAL SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(6) 2011 FROM A RESPIRATORY THERAPIST IN THE UNITED STATES REGARDING A (B)(6) NEONATE MALE WHO EXPERIENCED OXYGEN SATURATION DECREASED (SPO2 40%), EPISODES OF CARDIO-PULMONARY ARREST, AND ULTIMATELY DIED AFTER TAKING INOMAX AND HAVING AN INOMAX DS DEVICE ALARM ELECTRONIC SHUTDOWN. MEDICAL HISTORY/CO-MORBIDITIES INCLUDE: FULL TERM BIRTH (B)(6) 2011, WEIGHT (B)(6), POLYCYSTIC KIDNEYS, BLADDER MISSING, HYPO PLASTIC LUNGS, HEART NOT IN CORRECT POSITION, NUMEROUS CONGENITAL ANOMALIES NOS, AND INCREASED WBC COUNT. CONCOMITANT MEDICATION INCLUDED DOPAMINE. MOTHER'S CONDITION DURING PREGNANCY WAS NOT PROVIDED. BASELINE PO2 WAS 40% AND SPO2 WAS 80-90%. THE PHYSICIAN KNEW THE INFANT WOULD NOT SURVIVE, BUT PARENTS WANTED ALL EFFORTS MADE. ON (B)(6) 2011, THE PT WAS SENT TO THE NICU AT 14:22 TO FULFILL PARENTS WISHES, AND DUE TO EXTREMELY LOW PO2 (40'S) HE WAS STARTED ON INOMAX VIA INOVENT DS (B)(4) AT 20 PPM (PARTS PER MILLION) AT 21:55 VIA HFOV (HIGH FREQUENCY OSCILLATORY VENTILATOR) WITH FIO2 AT 100%, MAP:28, AMPLITUDE:55, AND FREQUENCY 10. WHILE ON INOMAX THE PT SPO2'S WERE IN THE 80-90%, UNTIL 4 AM ON (B)(6) 2011 AT WHICH TIME THE DEVICE ALARMED ELECTRONIC SHUTDOWN, AND THE PT'S SPO2 FELL TO 40%. THE PT WAS MANUALLY VENTILATED VIA INOBLENDER WITH OXYGEN VIA THE WALL, BUT HIS SPO2 REMAINED AROUND 50%. ACCORDING TO THE SITE NOTHING WAS BEING DONE WHEN THE DEVICE CEASED TO DELIVER NITRIC OXIDE (NO PROCEDURES). THE DEVICE WAS SWITCHED OUT TO A WORKING INOMAX DS AND THE SAT'S REMAINED LOW IN THE 40'S-50'S. AT 12:15 NOON THAT SAME DAY THE PT CODED AND WAS GIVEN CPR AND RESUSCITATED; HE CONTINUED TO HAVE EPISODES OF CARDIOPULMONARY ARREST AND LATER AT 5PM CODED AND DIED. THE ACTION TAKEN WITH THE INOMAX WAS NONE, HE CONTINUED ON INOMAX AT 20PPM UNTIL HIS DEATH. NO WITHDRAWAL OF LIFE SUPPORT DUE TO FAMILY WISHES. PRIMARY CAUSE OF THE PT'S DEATH WAS REPORTED BY THE NEONATOLOGIST AS PULMONARY HYPOPLASIA AND HYPOXIA. IT WAS UNI IF ANY AUTOPSY WAS PERFORMED. THE RPTR CONSIDERED THE EVENTS NOT RELATED TO THE INOMAX DS ALARMED ELECTRONIC SHUTDOWN, AND ALSO STATED THE PHYSICIANS FELT THE PT'S MULTIPLE CONGENITAL ANOMALIES WERE DETRIMENTAL TO HIS SURVIVING. THE INITIAL INOMAX DS WAS SENT FOR FURTHER INVESTIGATION. COMPANY COMMENT DATED (B)(6) 2011: WHILE THE WITHDRAWAL OF INO THERAPY DURING ELECTRONIC SHUTDOWN CANNOT BE EXCLUDED AS HAVING CONTRIBUTED TO THE PT'S SERIOUS DESATURATION, THE PT'S UNDERLYING CONGENITAL ABNORMALITIES AND POOR PROGNOSIS DO OFFER A LIKELY ALTERNATIVE EXPLANATION. THESE CONGENITAL ANOMALIES, INCLUDING LUNG HYPOPLASIA AND CARDIAC ABNORMALITY, ARE THE SUSPECTED ETIOLOGIES FOR THE PT'S EPISODES OF CARDIORESPIRATORY ARREST AND ULTIMATE DEMISE.

    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 1 DA Death| L| R OXYGEN| DOPAMINE