MAUDE Adverse Event Report: IKARIA INOMAX DSIR (DELIVERY SYSTEM); APPARATUS, NITRIC OXIDE DELIVERY

Model Number 10007

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Failed no sensor [device issue].No adverse event [no adverse event].Case description: on (b)(6) 2015, a respiratory therapist (rt) in the united states spoke with ikaria regarding an alarm condition of delivery failure (df) and a failed no (nitric oxide) fuel cell with inomax dsir# (b)(4).The device was in use on a patient and no adverse event had been reported.The reporter stated that the alarm had occurred while administering nebulizer treatment with an aerogen nebulizer to the patient.When asked, the reporter stated that they were not using the nebulizer disk filter during nebulization of albuterol and the ventilator that was being utilized for ventilation was a servo i from maquet.The rt was informed to utilize the nebulizer disk filter during the adminstration of nebulized medications and to position the nebulizer distal to the sample line on sample tee.It was reported by the rt that "she was pretty sure that they did not have these items in stock" and it was standard practice to position the nebulizer on the wet side on the fisher and paykel water chamber.Ikaria ts explained that two packages of part number 50086 would be sent to the facility for future use.The reporter further stated that she would inform the staff to utilize at all times when administering nebulized medications to the patients.Inomax dsir# (b)(4) was removed from service and returned to ikaria for service investigation.April 17, 2015: this is a non-serious, spontaneous post-marketing device report.No adverse patient consequence was reported in this case.The case is reportable because a previous case with similar device failure mode had resulted in serious adverse patient consequence (the index case mdr #3004531588-2013-00022).

Manufacturer Narrative

Device issue with inomax dsir# (b)(4) ((b)(4)).The device investigation was completed on april 10, 2015.Inomx dsir# (b)(4) was returned to the manufacturer for service investigation.The regional service center (rsc) investigation confirmed the reported complaint of a failed no cell alarm at bootup.The rsc did not experience a delivery failure (df) alarm and replaced the no (nitric oxide) cell.The service log review confirmed the reported complaint of a failed no cell alarm, which immediately followed a failed low no cell calibration with high point: 1209 counts, low point: 945 counts.Service log review also revealed a df alarm with monitored no >absolute max of 100 parts per million (ppm) actual vale: 101.Elevated low point counts during the calibration are consistent with the misbehaving no cell with the elevated counts possibly contributing to the df that occurred prior to the failed low calibration.A full functional test was performed and the device operated according to specifications so it was returned to the device service pool.The root cause for this report is no calibration low counts above maximum.This condition will be tracked and trended under ikaria's quality system.This case did not result in an adverse event/serious adverse event; however, it is being submitted to regulatory authorities because a similar failure occurred in the past which resulted in a serious adverse event (mdr 3004531588-2013-00022).

• Brand Name: INOMAX DSIR (DELIVERY SYSTEM)
• Type of Device: APPARATUS, NITRIC OXIDE DELIVERY
• Manufacturer (Section D): IKARIA; madison WI
• Manufacturer (Section G): IKARIA; 6603 femrite drive; madison WI 53718
• Manufacturer Contact: jane li, vp ; 53 frontage rd; po box 9001; madison, WI 53718 ; 9082386745
• MDR Report Key: 4726963
• MDR Text Key: 5580087
• Report Number: 3004531588-2015-00037
• Device Sequence Number: 1
• Product Code: MRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1