INOMAX DSIR (DELIVERY SYSTEM)

Description of Event or Problem

"INOMAX DSIR ALARMED FOR APPARENT NITRIC OXIDE SENSOR FAILURE" (DEVICE MALFUNCTION). INOMAX DSIR WAS NOT SET UP CORRECTLY (DEVICE MISUSE). UNABLE TO PERFORM HIGH CALIBRATION SINCE OUT OF NO HIGH CAL GAS (DEVICE MISUSE). CASE DESCRIPTION: ON (B)(6) 2013, A USER FACILITY DEVICE REPORT (B)(4) WAS RECEIVED FROM THE FDA REGARDING A MEDICAL DEVICE COMPLAINT INVOLVING AN INOMAX DSIR WITH THE "INO SET AT 10 APRTS PER MILLION AND THE NO SAMPLE LINE DISPLAY READING DROPPED" (MONITORED NO READING LOWER THAN SET NO) WHICH "CREATED AN ALARM FOR APPARENT NITRIC OXIDE SENSOR FAILURE." THE DEVICE WAS ON A PATIENT WITH NO HARM REPORTED. ON AN UNDISCLOSED DATE, THE REPORTER IN A HOSPITAL IN THE UNITED STATES FILED A VOLUNTARY USER FACILITY DEVICE REPORT FOR THE INOMAX DSIR (SERIAL NUMBER NOT PROVIDED). IT WAS REPORTED THAT ON (B)(6) 2013 THE INOMAX DSIR WAS IN USE ON A PREMATURE INFANT IN THE NEONATAL INTENSIVE CARE UNIT (NICU). ON THIS DATE, THE "INOMAX WAS SET AT 10 PARTS PER MILLION (PPM) AND THE NITRIC OXIDE (NO) SAMPLE LINE DISPLAY READING DROPPED." THE INO FILTER WAS CHANGED, A NEW INO TANK WAS CHANGED, AND THEN THE INO DELIVERY MACHINE WAS SWAPPED OUT, REMOVED FROM SERVICE AND RETURNED TO IKARIA FOR INSPECTION. THE PATIENT RECEIVED NO THROUGHOUT THE ISSUE AND THE PATIENT'S SPO2 REMAINED STABLE WITH NO REPORTED CARDIAC ISSUES. THE REPLACEMENT INOMAX DSIR DEVICE WAS MEASURING NO AT 10 PPM. DURING THE RT'S DISCUSSION WITH IKARIA TECHNICAL SERVICE, IT WAS DETERMINED THAT THE ALARM OCCURRED ON THE INOMAX DSIR IN QUESTION BECAUSE THE DEVICE WAS "NOT SET UP CORRECTLY." THE REPORTER STATED THAT "WHEN THE RT SWITCHED TO NEW INO DELIVERY MACHINES (INOMAX DSIR MODEL), THEY WERE NOT TOLD BY THE COMPANY THAT THE SET UP FOR NITRIC WOULD BE DIFFERENT IN WHERE THEY PLACED IT (INJECTOR MODULE) IN LINE WITH THE CIRCUIT." THE REPORTER STATED THAT "WITH THE NEW SYSTEM, THE RT NEEDS TO PUT IT AT THE HEATER DUE TO THE FLOW THAT COMES OUT OF THE SERVO I WITH THE NEW SYSTEM. " THE REPORTER STATED THAT "AFTER DISCUSSION WITH IKARIA, THE RT EDUCATED THE STAFF AND POSTED PICTURES OF WHAT THE NEW SET-UP SHOULD LOOK LIKE." A SEARCH OF THE IKARIA SAFETY DATABASE REVEALED NO SAFETY REPORTS FROM THIS FACILITY DURING THE TIMEFRAME INDICATED ON THE USER FACILITY. A SEARCH OF THE IKARIA COMPLAINT REPORTING DATABASE REVEALED A COMPLAINT RECEIVED BY IKARIA TECHNICAL SUPPORT SERVICES FROM THIS HOSPITAL ON (B)(6) 2013 (B)(4), THE RT SPOKE WITH IKARIA TECHNICAL SUPPORT REGARDING INOMAX DSIR (B)(4) THAT WAS "SET TO DELIVERY 10 PPM OF NO AND THE MEASURED NO VALUE WAS 1 TO 2 PPM." THE RT STATED THAT SHE CHANGED THE DISPOSABLES AND A LOW CALIBRATION WAS PERFORMED. THE RT STATED THAT SHE WAS OUT OF NO HIGH CAL GAS (NO HIGH CAL WAS PERFORMED). THE RT SWITCHED OUT THE DSIR WITH A BACKUP DEVICE (SERIAL NUMBER NOT PROVIDED) AND THE BACKUP DEVICE FUNCTIONED AS EXPECTED. THE RT STATED THERE WAS NO HARM TO THE PATIENT DURING THIS DEVICE ISSUE. THE INOMAX DSIR (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO IKARIA FOR SERVICE EVALUATION.

Additional Manufacturer Narrative

EVALUATION SUMMARY: THIS MANUFACTURE'S MDR IS BEING SUBMITTED IN RESPONSE TO THE RECEIPT OF A REPORT OF A USER MDR FROM OSB, AS IS IKARIA'S PRACTICE. THERE WAS NO ADVERSE EVENT REPORTED BY THE USER OR INDICATED AS A RESULT OF THE COMPLAINT INVESTIGATION. THE USER ATTEMPTED TO TROUBLESHOOT THE DEVICE, BUT DID NOT HAVE HIGH NITRIC OXIDE CALIBRATION GAS WITH WHICH TO PERFORM A FULL CALIBRATION. THE INOMAX DSIR DEVICE WAS SWITCHED OUT AND THERAPY WAS CONTINUED. THERE WAS NO PATIENT HARM REPORTED. THE DEVICE WAS RETURNED TO AN IKARIA SERVICE CENTER AS A RESULT OF A COMPLAINT RECEIVED BY IKARIA REGARDING NITRIC OXIDE VALUES MONITORED BY THE INOMAX DSIR DEVICE BEING LOWER THAN SET VALUES. FOLLOWING COMMUNICATION WITH IKARIA TECHNICAL SUPPORT, THE DEVICE WAS RETURNED FOR SERVICE INVESTIGATION. THE REPORTED ISSUE WITH MONITORED NITRIC OXIDE LESS THAN SET VALUES WAS CONFIRMED. THE DEVICE WAS THEN CALIBRATED AND IT PERFORMED TO SPECIFICATION FOLLOWING CALIBRATION. THE DEVICE WAS RETURNED TO THE DISTRIBUTION POOL. FAILURE TO MAINTAIN THE DEVICE PER MANUFACTURE'S INSTRUCTION CONTRIBUTED TO THIS INCIDENT SINCE HIGH CALIBRATION COULD NOT BE PERFORMED. THE STATEMENT INCLUDED IN THE USER MDR REGARDING A DIFFERENCE IN PLACEMENT OF THE INJECTOR MODULE ON DIFFERENT MODELS OF DELIVERY DEVICES IS NOT BORNE OUT BY FACT. THE OPERATOR'S MANUALS FOR ALL INOMAX DELIVERY DEVICES EVER DISTRIBUTED BY IKARIA INSTRUCT THE USER TO PLACE THE INJECTOR MODULE ON THE DRY SIDE OF THE HUMIDIFIER, AS ILLUSTRATED IN BREATHING CIRCUIT DIAGRAMS IN THE MANUALS. THE USER IS DIRECTED TO "INSERT THE INJECTOR MODULE ON THE DRY SIDE OF THE BREATHING CIRCUIT PRIOR TO HUMIDIFIER (THIS WILL ENSURE CORRECT FLOW MEASUREMENT)" AND "TO CONDITION THE FLOW AND ENSURE FLOW MEASUREMENT ARE ACCURATE, CONNECT THE INJECTOR MODULE TO THE HUMIDIFIER CHAMBER; THEN, CONNECT TO THE VENTILATOR RESPIRATORY PORT USING BREATHING CIRCUIT TUBING." THIS IS ALSO STRESSED DURING IN-SERVICE TRAINING. ON (B)(4) 2013, A USER FACILITY DEVICE REPORT ( B)(4) WAS RECEIVED FROM THE FDA REGARDING A MEDICAL DEVICE COMPLAINT INVOLVING AN INOMAX DSIR WITH THE "INO SET AT 10 PARTS PER MILLION AND NO SAMPLE LINE DISPLAY READING DROPPED" (MONITORED NO READING LOWER THAN SET NO) WHICH "CREATED AN ALARM FOR APPARENT NITRIC OXIDE SENSOR FAILURE." THE DEVICE WAS ON A PATIENT WITH NO HARM REPORTED. (B)(4).