INOMAX DSIR (DELIVERY SYSTEM)

Description of Event or Problem

MEASURED NO READING HIGHER THAN SET NO [DEVICE ISSUE], OXYGEN SATURATION AFTER DEVICE WENT INTO DELIVERY FAILURE [OXYGEN SATURATION DECREASED]. CASE DESCRIPTION: THIS INITIAL SERIOUS POST MARKETING REPORT WAS RECEIVED ON (B)(6) 2013 FROM A BIOMEDICAL TECH IN THE UNITED STATES WHO STATED THAT THE INOMAX DSIR (B)(4) WAS READING MONITORED NITRIC OXIDE (NO) HIGHER THAN SET NO AND DURING TROUBLESHOOTING THE DEVICE, THE PT HAD A SERIOUS OXYGEN DESATURATION FOLLOW-UP INFO WAS OBTAINED FROM THE BEDSIDE RESPIRATORY THERAPIST (RT) THE SAME DAY. THE PT WAS A CRITICALLY ILL ADULT MALE WITH A LONG CARDIAC HISTORY INCLUDING MITRAL VALVE REPLACEMENT AND PREVIOUS CORONARY ARTERY BYPASS GRAFT SURGERY. HE WAS ADMITTED TO THE INTENSIVE CARE UNIT ON (B)(6) 2013 PRIOR TO OPEN HEART SURGERY FOR REVISION OF CORONARY ARTERY BYPASS GRAFTS. THE PT WAS INTUBATED AND ON THE GE VENTILATOR ON 100% FRACTION OF INSPIRED OXYGEN CONCENTRATION (FIO2). POST-OPERATIVELY (DATE OF SURGERY NOT PROVIDED), THE PT WAS VERY UNSTABLE AND EXPERIENCED CARDIOGENIC SHOCK. ACCORDING TO THE RT, THE PT WOULD DESATURATE WHENEVER ANY PROCEDURE WAS PERFORMED ON HIM OR WHENEVER HE WAS TOUCHED. ON (B)(6) 2013, THE PT WAS STARTED ON INOMAX 30 PARTS PER MILLION (PPM) VIA THE INOMAX DSIR (B)(4) TO TRY AND IMPROVE HIS OXYGENATION. THE RT STATED THAT ON (B)(6) 2013, THE PT WAS VERY UNSTABLE AND HAD BEEN DESATURATING ALL MORNING. SHE STATED THAT DURING THE INSERTION OF LINES AND PERFORMANCE OF OTHER PROCEDURES (NOT SPECIFIED), THE PT CONTINUED DESATURATE DESPITE BEING ON 100% OXYGEN. VENTILATOR SETTINGS WERE TIDAL VOLUME 500ML, POSITIVE END EXPIRATORY PRESSURE (PEEP) 12 CM H2O, AND RESPIRATORY RATE 34. DURING A CHECK OF THE INOMAX DSIR ON (B)(6) 2013, THE RT NOTICED THAT ALTHOUGH THE SET NITRIC OXIDE (NO) DOSE WAS 30 PPM, THE MONITORED NO WAS READING 43 PPM. THE RT ATTEMPTED TO TROUBLESHOOT THE DEVICE AND SHUT THE DEVICE OFF THEN BACK ON. DURING TROUBLESHOOTING INOMAX DSIR (B)(4) WENT INTO DELIVERY FAILURE AND THE PT EXPERIENCED AN OXYGEN DESATURATION, DESCRIBED BY THE RT AS SERIOUS (SATURATION LEVELS NOT PROVIDED). SINCE THE PT HAD BEEN EXPERIENCING MULTIPLE EPISODES OF OXYGEN DESATURATION DURING THE SHIFT, NOT ASSOCIATED WITH A DEVICE ISSUE, THE RT FELT THAT THIS DESAT WAS RELATED TO THE PT'S OVERALL DETERIORATING CONDITION AND OT RELATED TO INOMAX OR THE INOMAX DSIR DEVICE. DURING THE MORNING OF (B)(6) 2013, AND PRIOR TO THE DEVICE ISSUE, THE FAMILY AGREED TO PLACE THE PT ON COMFORT CARE. RATHER THAN SETTING UP A NEW INOMAX DSIR UNIT TO REPLACE THE CURRENT UNIT, INOMAX THERAPY WAS DISCONTINUED AND ONLY COMFORT CARE WAS PROVIDED. SHORTLY AFTER TRANSITIONING TO COMFORT CARE ON (B)(6) 2013, THE PT EXPIRED. IT IS UNK IF AN AUTOPSY WAS ORDERED. THE INOMAX DSIR WAS REMOVED FROM SERVICE AND RETURNED TO IKARIA FOR INSPECTION.

Additional Manufacturer Narrative

(B)(4). CONCLUSION: INOMAX DSIR WITH SERIAL# (B)(4) IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF COMPLETION OF INVESTIGATION.