MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-06 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[3131508]
Fluctuating nitric oxide readings [device issue], pt desaturated [oxygen saturation decreased], off label use [off label use]. Case description: this initial spontaneous report rec'd on (b)(6) 2013, from a respiratory therapist (rt) nicu/picu clinical coordinator in the united states requesting to switch out the inomax dsir (b)(4) due to a device issue which resulted in pt oxygen desaturation. Add'l info rec'd on (b)(6) 2013 was included in this report. Relevant medical history/comorbidities included: full term male born on (b)(6) 2013, with meconium aspiration and low oxygen saturation levels. Concomitant medications not provided. On (b)(6) 2013, at 12 hrs of age, due to meconium aspiration and poor oxygenation, a decision was made to start the neonate on inomax therapy at 20 parts per million (ppm) via the inomax dsir (b)(4) in conjunction with high frequency jet ventilation. Jet settings were: inspiratory time (it). 020, rate 360, peak inspiratory pressure (pip) 38, positive end-expiratory pressure (peep) 8 and fraction of inspired oxygen (fio2) of 100%. According to the rt clinical coordinator, on (b)(6) 2013, at approx 04:00 the rt on duty observed that the monitor nitric oxide (no) was fluctuating from 3 ppm to 99 ppm; the device then went into delivery failure. The neonate's "spo2 decreased significantly to 40%" (baseline spo2 not provided) and "the device was switched off the pt. " the pt was manually ventilated with the inoblender at 100% fio2 and 20 ppm no during the switch out. The rt clinical coordinator stated that if they couldn't get the second device to work properly they were going to put the pt on extracorporeal membrane oxygenation (ecmo). The second inomax dsir functioned properly on 20 ppm, the "pt's spo2 increased to normal values" and ecmo was averted. The device was examined by hospital risk management and returned to ikaria for inspection. The rptr deems the event of oxygen desaturation as serious and possibly related to the inomax dsir.
Patient Sequence No: 1, Text Type: D, B5
[10565096]
On (b)(6) 2013, the respiratory therapy clinical coordinator reported that the monitor nitric oxide (no) was fluctuating from 3 ppm to 99 ppm and inomax dsir (b)(4) then went into delivery failure while in use on a pt (b)(4). The device was returned to the mfr for service investigation. The device was tested and a fluctuating sample system flow rate was observed which can result in fluctuating monitored no readings as was observed by the rt. In this situation, these fluctuating monitored no readings likely do not accurately represent the delivered dose as the sample system requires a consistent sample flow rate to function properly. The device logs were evaluated and it was confirmed that the device stopped the delivery as designed when these incorrect monitored no readings exceeded the 100 ppm maximum limit. The sample system was inspected visually and white/gray substance was observed on the vent of the zero valve. The zero valve was replaced to address the issue with the flow rate and several other sample system components were also replaced as a precautionary measure due to the possibility that these components were also contaminated with this substance. The system was retested after the replacement of the sample system components and met all specifications. While the source of the contamination cannot be determined definitively, the presence of such a substance is consistent with sodium build-up from humidified and nebulized medication traveling through the sample system. The inomax dsir labeling instructs the user to place medication nebulizer downstream of the sample tee to avoid contamination of the sample system. In addition, it is unk whether a sample line filter was used as indicated in the labeling to minimize sample system contamination. The root cause for this incident was a zero valve that was not able to maintain a consistent sample flow rate due to contamination that had entered the sample system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2013-00006 |
| MDR Report Key | 2997735 |
| Report Source | 05 |
| Date Received | 2013-03-06 |
| Date of Report | 2013-02-05 |
| Date of Event | 2013-02-05 |
| Date Mfgr Received | 2013-02-05 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2013-05-13 |
| 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 RA |
| Manufacturer Street | 2902 DAIRY DRIVE |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal | 53718 |
| Manufacturer Phone | 6083953910 |
| Manufacturer G1 | INO THERAPEUTICS LLC |
| Manufacturer Street | 2902 DAIRY DRIVE |
| 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 | APARATUS, NITRIC OXIDE DELIVERY |
| Product Code | MRQ |
| Date Received | 2013-03-06 |
| Model Number | 10007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2013-03-06 |