MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-18 for EDWARDS CO-SET+ 93610 * manufactured by Edwards Lifesciences Ag.
[4820320]
Cardiac output flush tubing did not function properly. Tubing is designed to not backflow unless manual pressure is applied to the syringe to withdraw fluid. This was not working. Tubing and syringe were saved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3994199 |
| MDR Report Key | 3994199 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-07-18 |
| Date of Event | 2014-06-25 |
| Report Date | 2014-07-18 |
| Date Reported to FDA | 2014-07-18 |
| Date Reported to Mfgr | 2014-08-08 |
| Date Added to Maude | 2014-08-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDWARDS CO-SET+ |
| Generic Name | FLOWMETER, BLOOD, CARDIOVASCULAR |
| Product Code | DPW |
| Date Received | 2014-07-18 |
| Model Number | 93610 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES AG |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-18 |