MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2012-03-27 for INOBLENDER 10004 manufactured by Ino Therapeutics Llc/ikaria.
[2577341]
This initial spontaneous medical device report was received on (b)(6) 2012 from a respiratory therapist in (b)(6) regarding a (b)(6) premature male infant who experienced oxygen saturation decreased and device misuse. Relevant medical history/co-morbidities included: premature birth at (b)(6) on (b)(6) 2012 with a birth weight of (b)(6), respiratory insufficiency, metabolic acidosis, decreased oxygen saturation, patent ductus arteriosus, and very low birth weight. No concomitant medications were reported. Although the pt was on jet hfov (high frequency oscillating ventilation) at 100% fio2 (for an unk period of time), he still had low oxygen saturations (in the lower 80s%). Therefore, on (b)(6) 2012 the pt was started on inomax via inomax dsir (jet ventilator was continued) at 20 ppm. On (b)(6) 2012, the average spo2 was 86% (range of 75-92%); the levels were stable thereafter. On (b)(6) 2012, the nurses were reportedly moving the pt and had to disconnect the inomax dsir. At this time, the nurses tried to use the inoblender for backup therapy, however, the inoblender knob was difficult to turn, therapy could not be delivered, and the pt started to experience a serious oxygen saturation decrease. The rt was called for assistance. The reporter stated that the pt's saturations dropped down into the "teens" and remained there for (approx) <5 minutes while the rt tried to turn the inoblender knob to start therapy. Once the rt was able to move the knob on the inoblender and therapy was re-initiated, the pt stabilized and his spo2 returned to baseline. The inoblender was switched out and returned to the mfr for eval. Outcome of the event of oxygen saturation decreased was resolved in less than 5 minutes. The reporter considered the event oxygen saturation decreased possibly related. Alternative explanation was the reported movement of the pt by the nurses.
Patient Sequence No: 1, Text Type: D, B5
[9722257]
On (b)(6) 2012, a respiratory therapist reported an inoblender (b)(4) knob was difficult to move and unable to use temporarily. ((b)(4)). When the inoblender was returned to a service center for investigation, it was found to operate per spec. However, the dose knob was found to be broken. Per the user report, the dose knob and the o2 flow control knob were found to be inoperable when the user initially attempted to use the inoblender for nitric oxide delivery. The inoblender was made operational only after sufficient force was applied to the dose knob to fracture it. The device was not repairable due to mechanical distortion of the controls mounting mechanism, most likely caused by dropping it or otherwise applying sufficient external force to damage the inoblender. This condition would have been detected had the user conducted a pre-use checkout as advised in labeling and during in-service training. The root cause of this incident was user error in not conducting the pre-use checkout procedure, which would have detected the damage that had previously occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2012-00002 |
| MDR Report Key | 2508839 |
| Report Source | 00,05 |
| Date Received | 2012-03-27 |
| Date of Report | 2012-03-27 |
| Date of Event | 2012-02-23 |
| Date Mfgr Received | 2012-02-27 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2012-03-29 |
| 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 DR |
| 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 | INOBLENDER |
| Generic Name | APPARATUS, NITRIC OXIDE, BACKUP DELIVERY |
| Product Code | MRO |
| Date Received | 2012-03-27 |
| Model Number | 10004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Other | 2012-03-27 |