INOMAX DSIR (DELIVERY SYSTEM)

Additional Manufacturer Narrative

INOMAX DSIR SERIAL NUMBER (B)(4) WAS RETURNED TO THE MANUFACTURER FOR A SERVICE INVESTIGATION. THE IKARIA REGIONAL SERVICE CENTER (RSC) REVIEWED THE SERVICE LOG AND FINDINGS CONFIRMED THE REPORTED COMPLAINT OF A FAILED LOW NO CELL CALIBRATION WITH LOW POINT COUNTS (686) ABOVE THE MAXIMUM ALLOWED 655 COUNTS CONSISTENT WITH A MISBEHAVING NO CELL. THE LOG ALSO CONFIRMED THE REPORTED FAILED NO SENSOR ALARM IMMEDIATELY FOLLOWING THE FAILED LOW CALIBRATION WITH 678 CONCENTRATION COUNTS ALSO ABOVE THE MAXIMUM ALLOWED 655 COUNTS AND CONSISTENT WITH THE OBSERVED NO CELL MISBEHAVIOR. TWO ADDITIONAL FAILED NO SENSOR ALARMS OCCURRED LATER IN THE DAY, AND WERE NOTED TO HAVE BEEN CLEARED FOLLOWING THE NEXT SUCCESSFUL LOW CALIBRATION WHEN THE NO CELL REPORTED CONCENTRATION COUNTS (321) WERE WITHIN RANGE AND BELOW THE MAXIMUM ALLOWABLE COUNTS. A FURTHER LOG REVIEW CONFIRMED SENSOR CALIBRATIONS HAD BEEN DONE AS PRESCRIBED BY THE DEVICE INSTRUCTIONS FOR USE. THE RSC INVESTIGATION WAS UNABLE TO REPRODUCE THE NO MONITORING ANOMALIES BUT REPLACED THE NO SENSOR DUE TO THE PREVIOUS LOGGED BEHAVIOR. THE ROOT CAUSE FOR THIS DEVICE ISSUE WAS NO CALIBRATION LOW COUNTS ABOVE MAXIMUM. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER IKARIA'S QUALITY SYSTEM. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECIFICATIONS SO IT WAS RETURNED TO THE DEVICE SERVICE POOL.

Description of Event or Problem

NO SENSOR FAILED, HIGH NO ALARM [DEVICE ISSUE] 02 DESATURATION TO 84% FOR 30 MINS [OXYGEN SATURATION DECREASED]. CASE DESCRIPTION: THIS INITIAL SERIOUS DEVICE CASE REPORT WAS RECEIVED ON (B)(6) 2014 FROM A RESPIRATORY THERAPIST (RT) IN (B)(6) WHO CONTACTED AN IKARIA CLINICAL SPECIALIST (CS) REGARDING A DEVICE ISSUE WITH INOMAX DSIR# (B)(4). DURING A CALL TO IKARIA DRUG AND DEVICE SAFETY (DDS) LATER THE SAME DAY, THE RT REPORTED THAT AT THE TIME OF THE DEVICE ISSUE THE PATIENT EXPERIENCED AN OXYGEN DESATURATION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 IS INCLUDED IN THIS REPORT. RELEVANT MEDICAL HISTORY/CO-MORBIDITIES: "COMPLEX PROBLEMS", PREMATURE (B)(6) WEEKS (NO APGAR SCORE WAS SPECIFIED), PREMATURE LUNGS, INTUBATED AND MECHANICAL VENTILATION. A (B)(6) PREMATURE MALE NEONATE WAS INTUBATED AND ATTACHED TO THE BABYLOG VN 500 IN HFO MODE (ADDITIONAL SETTINGS WERE NOT PROVIDED). THE NEONATE WOULD NOT OXYGENATE WHILE ON HIGH FI02, SO ON (B)(6) 2014 THE PATIENT WAS STARTED ON INOMAX (CYLINDER SERIAL NUMBER WAS NOT SPECIFIED) AT 15 PPM VIA INOMAX DSIR (B)(4). THE RT STATED THAT THE PATIENT HAD NO CARDIAC PROBLEMS. NO INFORMATION WAS PROVIDED ON WHETHER AN ECHOCARDIOGRAM OR CHEST X-RAY WAS COMPLETED. IT WAS REPORTED BY THE RT THAT THE MONITORED NO (NITRIC OXIDE) LEVEL SUDDENLY INCREASED TO 40 WITH A SET DOSE OF 15, AND CONTINUED TO RISE. THE INOMAX DSIR WAS BEING USED WITH THE VN 500 IN HFO MODE AND THE ONE WAY VALVE WAS IN PLACE AND FUNCTIONAL (FLAPPING). IT WAS REPORTED THAT THE PATIENT HAD BEEN ON THESE SETTINGS FOR HOURS AND WITHOUT ANY ISSUES. A LOW CALIBRATION WAS PERFORMED AND THE NO SENSOR FAILED. THE RT THEN DECIDED TO SWITCH OUT THE DEVICE. THE PATIENT WAS DISCONNECTED AND BAGGED WITH THE INOBLENDER WHILE DSIR (B)(4) WAS REMOVED FROM THE PATIENT AND THERAPY WAS CONTINUED USING ANOTHER INOMAX DSIR ((B)(4)). DURING THE DEVICE ISSUE, THE PATIENT EXPERIENCED A DESATURATION FROM BASELINE (90-92%) TO 84%. IT WAS REPORTED THAT IT TOOK 30 MINUTES FOR THE PATIENT'S OXYGEN SATURATION TO RETURN TO 90%. AS OF (B)(6) 2014, THE PATIENT REMAINED ON THERAPY VIA INOMAX DSIR (B)(4) AND WAS RECEIVING INOMAX AT 20 PPM.