INOMAX DSIR (DELIVERY SYSTEM)

Description of Event or Problem

DEVICE WENT INTO DELIVERY FAILURE DURING PT SUCTIONING [DEVICE ISSUE] HYPOXIA [HYPOXIA]. CASE DESCRIPTION: THIS INITIAL SPONTANEOUS REPORT WAS RECEIVED BY IKARIA CUSTOMER CARE ON (B)(6) 2013 FROM A RESPIRATORY THERAPIST (RT) IN THE UNITED STATES WHO REPORTED THAT THE INOMAX DSIR ((B)(4)) WENT INTO DELIVERY FAILURE AFTER THE PT WAS SUCTIONED. THE RT REPORTED THAT THE DELIVERY FAILURE "POTENTIALLY CAUSED HARM" TO THE PT. FOLLOW UP INFO WAS RECEIVED ON (B)(6) 2013 AND IS INCLUDED IN THIS REPORT. RELEVANT MEDICAL HISTORY/COMORBIDITIES INCLUDES: FULL TERM MALE NEONATE BORN ON (B)(6) 2013 WITH CONGENITAL DIAPHRAGMATIC HERNIA AND PERSISTENT PULMONARY HYPERTENSION. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THIS CRITICALLY ILL NEONATE WAS INTUBATED AND ON THE BUNNELL JET VENTILATOR (FREQUENCY 420, PEAK INSPIRATORY PRESSURE (PIP) 40 CM H20, SERVO PRESSURE 5.7 PSI, POSITIVE END-EXPIRATORY PRESSURE (PEEP) 6 CM H20, FRACTIONAL INSPIRED OXYGEN CONCENTRATION (FIO2) 100%). CONVENTIONAL VENTILATOR SETTINGS WERE: RESPIRATORY RATE 2 BREATHS PER MINUTE, PRESSURE CONTROL 24 CM H2O, PEEP 6 CM H2O, FIO2 100%, MEAN AIRWAY PRESSURE (MAP) 10.6 CM H2O. INOMAX WAS STARTED ON AN UNKNOWN DATE, AT AN UNKNOWN DOSE VIA THE INOMAX DSIR (SERIAL NUMBER (B)(4)). ON (B)(6) 2012 THE RT PLACED THE HIGH FLOW JET VENTILATOR ON STANDBY WHILE THE PT WAS SUCTIONED WITH "A QUICK PASS, LESS THAN 10 SECONDS" INLINE SUCTION CATHETER. WHEN THE HFJV WAS PLACED BACK IN VENTILATION MODE, THE RT NOTICED THAT THE NO MONITORED READING SHOWED 90 PARTS PER MILLION (PPM); THE DEVICE WENT INTO DELIVERY FAILURE. THE PT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED WITH THE INOBLENDER SET AT 20 PPM OF INOMAX AND 100% OXYGEN. THE RT STATED THAT THE PT EXPERIENCED HYPOXIA. THE RT STATED THAT THE PT'S BASELINE PAO2 VALUE WAS 95 (SPO2 96%) BEFORE SUCTIONING; AFTER SUCTIONING AND DEVICE DELIVERY FAILURE HIS PAO2 DECREASED TO 59 (SPO2 30%). THE RT ATTEMPTED TO RE-BOOT THE INOMAX DSIR HOWEVER IT WENT BACK INTO DELIVERY FAILURE. THE INOMAX DSIR ((B)(4)) WAS SWITCHED OUT WITH ANOTHER DEVICE AND RETURNED TO IKARIA FOR INSPECTION. THE RT REPORTED THAT ON (B)(6) 2013 THE PT WENT ONTO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE RT CONSIDERS THE EVENT OF HYPOXIA AS LIFE THREATENING AND RESOLVED WITH SEQUELAE.

Additional Manufacturer Narrative

ON (B)(6) 2013 A RESPIRATORY THERAPIST (RT) IN THE UNITED STATES REPORTED THAT THE INOMAX DSIR ((B)(4)) WENT INTO DELIVERY FAILURE AFTER THE PATIENT WAS SUCTIONED. THE RT REPORTED THAT THE DELIVERY FAILURE "POTENTIALLY CAUSED HARM" TO THE PATIENT. (B)(4). THE 11-INOMAX DSIR WITH SERIAL #: ((B)(4)) IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF COMPLETION OF INVESTIGATION.