MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-15 for INOMAX DS (DELIVERY SYSTEM) 10003 manufactured by Ino Therapeutics, Llc/ikaria.
[2314755]
On (b)(6) 2011, a biomedical technician called to report that an inomax ds ((b)(4)) failed calibration while on a patient resulting in the generation of an incident report due to impact to the patient and the device being sent to biomed for inspection. The biomedical department contacted ikaria customer care to arrange for return of device for inspection. A follow up phone call to the quality manager (qm) of respiratory services revealed that a (b)(6) female was on the servo i ventilator with a fractional inspired oxygen (fio2) of 93% and inomax (nitric oxide) via the inomax ds ((b)(4)) at 20 parts per million (ppm). The infant's oxygen saturation level was spo2 99%. The infant was receiving ino therapy for "pulmonary hypertension and had been on therapy for awhile". According to the qm, the nurse called the respiratory therapist (rt) into the patient's room when the "service required" alarm sounded on the inomax device. The rt attempted to troubleshoot and calibrate the device. When the device failed calibration, a decision was made to switch out the device with another unit. During the start of the switch out, the infant desaturated from her baseline of spo2 99% to spo2 70%. The rt started manual ventilations with the inoblender and the infant quickly came back up to near baseline of spo2 94%. The switch out took approximately 15 minutes during which time the infant continued to be manually ventilated with the inoblender and had no further problems with oxygen desaturation. The reporter could not determine, from the incident report, the exact amount of time the infant's spo2 was at 70%, but felt it "probably wasn't too long since the rt was at the infant's bedside and was preparing to manually ventilate the infant when she started to desaturate". The qm "did not consider the event of oxygen desaturation serious due to the infant's quick return to near baseline oxygen saturation levels with the initiation of the inoblender manual ventilations. " she also stated that "the event was probably related to interruption in ino therapy due to device switch out. " the initial inomax device was removed from service and sent to the hospital's biomedical department for inspection. The biomedical department contacted ikaria customer care to arrange for return of device. The device was returned to ikaria for inspection.
Patient Sequence No: 1, Text Type: D, B5
[9498006]
On (b)(6) 2011, a biomedical technician called to report that an inomax ds ((b)(4)) failed calibration while on a patient resulting in the generation of an incident report due to impact to the patient and the device being sent to biomed for inspection. The biomedical department contacted ikaria customer care to arrange for return of device for inspection. The biomedical department contacted ikaria customer care to arrange for return of device for inspection. ((b)(4)). The investigation of the device is complete and is as follows. The device was being used in an off-label, long-term application which was not anticipated. A review of the service logs yielded the alarm, "service required" resulting in a system shutdown. A software anomaly was found to be the root cause of the incident. The software has been modified to eliminate the anomaly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2011-00042 |
| MDR Report Key | 2354775 |
| Report Source | 05 |
| Date Received | 2011-11-15 |
| Date of Report | 2011-11-15 |
| Date of Event | 2011-08-04 |
| Date Mfgr Received | 2011-08-04 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2012-07-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID TRUEBLOOD |
| Manufacturer Street | 2902 DAIRY DRIVE |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal | 53718 |
| Manufacturer Phone | 6083953910 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOMAX DS (DELIVERY SYSTEM) |
| Generic Name | APPARATUS, NITRIC OXIDE DELIVERY |
| Product Code | MRP |
| Date Received | 2011-11-15 |
| Model Number | 10003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INO THERAPEUTICS, LLC/IKARIA |
| Manufacturer Address | MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-15 |