MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-03-26 for DIAL FLOWMETER F10-2G0A3 UNK manufactured by Amvex Corporation.
[18805729]
Per the model and serial number provided by the initial reporter, the device in question is not determined to be an amvex product. Furthermore, amvex dial flowmeters are not designed to have device set at points between identified settings. In example, dial settings are for use at 6 liters per minute and 8 liters per minute. No such setting exist at 7 liters per minute.
Patient Sequence No: 1, Text Type: N, H10
[18971400]
Title: xxxxx. Event desc: ecmo [extracorporeal membrane oxygenator] sweep flowmeter was adjusted from 6 l/m [liters per minute] to 7 l/m [liters per minute]. The flowmeter does not have a 7 l/m [liter per minute] setting. It has settings at 6 then 8 l/m [litters per minute]. At the in between area there was no oxygen flow. The pt became hypoxic. The md was notified and the oxygen device was changed. During rounds, team wanted sweep to be turned from 6 to 7. At this time bedside rn notified ecmo and proceeded to increase sweep to 7. A few minutes later sats [saturations] began to drop significantly (lowest of 12%) as well as svo2 [extracorporeal membrane oxygenator] charge immediately called to bedside as well as attending md, rt [respiratory therapist] and charge rn. Attending at bedside with bedside rns assessing pt and ecmo equipment. Oxygen from wall appeared to be working at times and at others not, so ecmo flow meter attached to oxygen tank and sweep increased on dial per md. At this time, sats began to increase as well as svo2 [mixed venous oxygen membrane saturation]. At this time ecmo at bedside and explained that the ecmo sweep dial turns off when dial adjusted to 7 and needs to be changed to a different flow meter to increase sweep to 7. Sicu staff unaware of this info. Pt vitals returned to normal with no apparent complications noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617620-2012-00003 |
| MDR Report Key | 2508692 |
| Report Source | 00 |
| Date Received | 2012-03-26 |
| Date of Report | 2011-04-16 |
| Date of Event | 2011-01-21 |
| Report Date | 2011-04-01 |
| Date Reported to FDA | 2011-04-01 |
| Date Added to Maude | 2012-09-05 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1111 LAKESIDE DRIVE |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal | 60031 |
| Manufacturer Phone | 8478550500 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAL FLOWMETER |
| Generic Name | FLOWMETER |
| Product Code | CAX |
| Date Received | 2012-03-26 |
| Model Number | F10-2G0A3 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMVEX CORPORATION |
| Manufacturer Address | 1111 LAKESIDE DRIVE GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-26 |