MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-12-04 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[2953664]
High no alarm/delivery failure [device issue]. Desaturation to 48% [oxygen saturation decreased]. Heart rate "began to bottom out" [heart rate decreased]. Blood pressure "began to bottom out" [blood pressure decreased]. Patient experienced a pneumothorax [pneumothorax]. Case description: this initial spontaneous report was received on (b)(6) 2012 from a respiratory therapist (rt) in the united states. The rt contacted an ikaria clinical specialist to report a delivery failure of inomax dsir device #(b)(4) while on a patient. Follow up information received on (b)(6) 2012 provided by the rt was included in this report. Relevant medical history included: diabetes, hypertension, hyperlipidemia, atrial fibrillation and cryptogenic organizing pneumonia. No concomitant medications were provided. According to the rt, the (b)(6) female patient had been in the intensive care unit (icu) in unstable condition, on ventilator support for one week prior to this report, reportedly for pulmonary problems and/or pneumonia. The patient was on a puritan bennet 840 ventilator assist/control at respiratory rate (rr) 30 breaths per minute, tidal volume 300 ml, peak inspirator pressure (pip) 25 cm h2o, positive end expiratory pressure (peep) 10 cm h2o, fraction of inspired oxygen (fio2) 100%. The patient's respiratory status continued to deteriorate, and at 01:20 on (b)(6) 2012 the patient was started on inomax via inomax dsir device #(b)(4) at 10 parts per million (ppm). At 17:00, her inomax dose was increased to 40 ppm, fio2 remained at 100% and oxygen saturation was reading 90%. At 21:45, the patient's oxygen saturation was reading 73% on an fio2 of 100% and inomax dose of 40 ppm (oxygen desaturation on inomax therapy). On (b)(6) 2012 at 03:45, the patient's oxygen saturation levels were still in the low 70's, so the inomax dose was increased to 70 ppm; however the patient's oxygen saturation levels remained unchanged, the rt stated that an m. D. At the patient's bedside turned the inomax dose upwards toward 80 ppm, and following the dose increase, inomax dsir device #(b)(4) alarmed 'high no' and went into delivery failure. At the time of the delivery failure, the ventilator was set at pip 40 cm h2o, peep 14-15 cm h2o, and fio2 100% and the patient's oxygen saturation was in the 70's% (exact value nos). At an unspecified time, the patient began to desaturate while still on 100% fio2; the nurse removed the patient from the ventilator and started to bag the patient with the ambu bag connected to wall oxygen. The patient's oxygen saturation level decreased to 48% and the rt switched the patient to hand ventilation via the inoblender, delivering both inomax and oxygen therapy. The rt also stated that "the patient's heart rate and blood pressure began to bottom out" but "the patient did not require resuscitation since her heart rate, blood pressure and oxygen saturation level began to come up" again. The rt was unable to determine the length of time the patient's oxygen saturation was at 48%. The patient returned to baseline (oxygen saturation in the 70's%) while being hand ventilated. Due to her unstable condition, a decision was made to switch out the inomax dsir with a new device rather than attempt to trouble shoot the current device. The patient was hand ventilated via the inoblender with inomax and oxygen for approximately 45 minutes, while another rt assisted with the setup and testing of the new device. The patient was then placed on the replacement inomax delivery device at 70 ppm. After the patient was back on the device and ventilator, an arterial line was placed and chest x-ray was performed. The chest x-ray revealed a pneumothorax and two chest tubes were inserted. Oxygen saturation improved slightly after chest tube placement (parameters not provided). On (b)(6) 2012, the rt spoke with the ikaria clinical specialist and informed him that at the time, the patient was on 20 ppm inomax with no device issues. The patient was discontinued from inomax therapy on (b)(6) 2012 (details not specified). Inomax dsir #(b)(4) was returned for inspection. The rt considered the event of oxygen desaturation possibly related to the delivery failure of the inomax dsir device #(b)(4) and also related to the patient's unstable respiratory status. The rt considered the event of pneumothorax to be unrelated to the inomax or inomax dsir device, but rather a possible complication of the patient's pre-existing respiratory problems. The reporter did not comment on the causality of the heart rate decreased and blood pressure decreased following the delivery failure of the inomax dsir device. Also, the rt did not provide causality for the patient's oxygen saturation decrease that occurred while the patient was receiving treatment with inomax. Company comment dated (b)(4) 2012: this (b)(6) patient was intubated in the micu for approximately 1 week prior to starting ino therapy. Although baseline saturations prior to therapy initiation were not provided, the patient reportedly improved on ino, with an on drug baseline of 90%. Based upon the clinical details provided, the following clinical scenario can be surmised. At some point over the 4 hours following ino initiation, the subject developed a new or worsening pneumothorax, likely due to the mechanical ventilation. It was because of the pneumothorax that the patient's oxygen saturation subsequently dropped from 90% to 73%. An m. D. At bedside, unaware that a pneumothorax had developed, attempted to increase the patient's o2 saturations back towards 90% by increasing the ino dose. However, an increased dose of ino could not correct for the decrease in oxygenation caused by the pneumothorax. Furthermore, because of the increased pressure in the patient's chest cavity and subsequent increase in pressure in the ventilation circuit, the increased ino dose caused the monitored ino within the delivery device to rise to a level that resulted in termination of delivery. Subsequent to termination of delivery, the patient had additional and expected events including decrease in oxygen saturation, bradycardia, and hypotension likely due to rebound pulmonary hypertension.
Patient Sequence No: 1, Text Type: D, B5
[10262438]
On (b)(6) 2012 a respiratory therapist contacted an ikaria clinical specialist to report that inomax dsir device ((b)(4)) alarmed delivery failure while in use on a patient ((b)(6)). Evaluation summary: when the inomax dsir was returned for service investigation, the no sensor was found to be out of calibration. Examination of the service log revealed a delivery failure due to high no concentration as reported by the user. Subsequent to this delivery failure, the service log indicates that the user then incorrectly performed a high range no sensor calibration by using the gas from the ventilator with the no backup delivery running instead of using the 45 ppm calibration gas cylinder as indicated in the instructions for use. After this incorrect high range no sensor calibration was performed, the no sensor was reading no concentration values that were much greater than the actual no concentration in the circuit and the system experienced multiple high no concentration delivery failures as a result. It was verified during the service investigation that a dose setting of 70 ppm was incorrectly reading 144 ppm by the no sensor. A high range no sensor calibration was performed using the correct calibration gas and after this was done, the measured no concentrations were within the specifications of the device. The root cause of this issue was a user error where a high range no sensor calibration was performed with the incorrect calibration gas.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2012-00014 |
| MDR Report Key | 2859845 |
| Report Source | 05,07 |
| Date Received | 2012-12-04 |
| Date of Report | 2012-11-05 |
| Date of Event | 2012-11-04 |
| Date Mfgr Received | 2012-11-05 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2012-12-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID TRUEBLOOD, DIRECTOR |
| Manufacturer Street | 2902 DAIRY DR. |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal | 53718 |
| Manufacturer Phone | 6083953910 |
| Manufacturer G1 | IKARIA |
| Manufacturer Street | 2902 DAIRY DR. |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53718 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOMAX DSIR (DELIVERY SYSTEM) |
| Generic Name | APPARATUS, NITRIC OXIDE DELIVERY |
| Product Code | MRP |
| Date Received | 2012-12-04 |
| Model Number | 10007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IKARIA |
| Manufacturer Address | MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2012-12-04 |