MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-15 for INOBLENDER (BACKUP DELIVERY SYSTEM) 10004 manufactured by Ikaria.
[3959019]
Oxygen flowmeter knob on inoblender was stuck in the off position [device issue]. Heart rate dropped [heart rate decreased]. Sats dropped [oxygen saturation decreased]. Case description: a maude event report (b)(4) received from the fda on march 18, 2013 stated "the knob on the ino machine was stuck in the off position and could not be turned". The maude report did not provide the model or serial number of the device but did include the date of the event and the reporter/facility information. A search of the complaint and safety databases by facility revealed that the same facility contacted ikaria on (b)(6) 2013. The rt reported to ikaria that a baby on inomax who needed to be suctioned experienced a decrease in heart rate and oxygen saturation which was exacerbated and prolonged by a device issue. Additional information was obtained on (b)(6) 2013. Relevant medical history/co-morbidities: 1 month old full term female, pulmonary hypertension, arch reconstruction, ventricular septal defect (vsd) closure, residual vsd-patch dehiscence, left ventricular-right atrial (lv-ra) shunt, and congestive heart failure (chf)/pulmonary overcirculation. A female infant status post cardiac surgery with pulmonary hypertension was on ventilator (settings and type were not provided) and was receiving inomax (dose unspecified) via inomax dsir# (b)(4). On (b)(6) 2013 a nurse was alerted via a monitor that the baby's heart rate had dropped into the 90s (baseline 130s) and that her oxygen saturation was in the low 80s (baseline 100%). Recognizing that the baby needed to be suctioned, the nurse attempted to turn the oxygen flowmeter knob on the inoblender (b)(4) so that she could use the device to manually ventilate the baby. The nurse reported that the knob was "stuck in the off position" and that she could not turn it. While the nurse continually tried to turn the knob, the baby's "heart rate and sats dropped" she confirmed that heart rate did not drip below the 90s nor did the oxygen saturation drop below the low 80s. A male rt was summoned, he was able to turn the oxygen flowmeter knob on, and within a minute the baby's heart rate and oxygen saturation improved (nos). It was noted that the baby "recovered" after she was suctioned and sedated. Inoblender (b)(4) was removed from service by the customer and was returned to the company for investigation. According to the director of respiratory therapy at the facility, whenever the rt is calibrating the machines they are turning the knob for the flowmeter all the way off, which "makes it hard to turn the flow back on". The ikaria ccbm provided a training/in service to the rt staff on (b)(6) 2013. The nurse considered the exacerbated and prolonged decrease in heart rate and oxygen saturation to be related to the device issue. The nurse did not report whether the event was related to inomax.
Patient Sequence No: 1, Text Type: D, B5
[11021779]
The maude event report (b)(4) received from the fda on march 18, 2013 stated "the knob on the ino machine was stuck in the off position and could not be turned". Evaluation summary: the inoblender was returned for service investigation. The oxygen flow control knob turned freely when tested by the service technician. The oxygen flow control knob on the inoblender is turned on and then shut off as part of the inomax dsir pre-use checkout procedure performed by users prior to use of the device on each patient. Therefore, the most likely root cause for the observation of the nurse is that the knob was turned too tightly when the oxygen flow was shut off by the rt during the most recent pre-use checkout procedure. As indicated in the event description above, an ikaria representative did provide training to the rt staff at the facility on (b)(6) 2013 to address this issue. It should be noted that this mdr is being submitted in response to a voluntary maude report submitted by the hospital, as is ikaria's practice. A medwatch form was not submitted at the time the event was originally reported to ikaria by the hospital because there was no indication that serious injury had occurred to the patient and no device malfunction was detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2013-00009 |
| MDR Report Key | 3312755 |
| Report Source | 05 |
| Date Received | 2013-04-15 |
| Date of Report | 2013-03-18 |
| Date of Event | 2013-02-07 |
| Date Mfgr Received | 2013-03-18 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2013-09-05 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID TRUEBLOOD, DIRECTOR |
| Manufacturer Street | 2902 DAIRY DRIVE |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal | 53718 |
| Manufacturer Phone | 6083953910 |
| Manufacturer G1 | IKARIA |
| 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 | INOBLENDER (BACKUP DELIVERY SYSTEM) |
| Generic Name | APPARATUS, NITRIC OXIDE, BACKUP DELIVERY |
| Product Code | MRO |
| Date Received | 2013-04-15 |
| Model Number | 10004 |
| 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 | 2013-04-15 |