MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-12 for AQUARIUS GEF09800 * manufactured by Edwards Lifesciences.
[21370329]
After starting the hemodialysis system, the degassing alarm sounded, and troubleshooting efforts were unsuccessful in resolving the problem. The nurse recognized that blood was starting to clot in the tubing, and recirculated the blood back to the patient. The tubing was then replaced with new tubing. The alarm sounded again and the same problem of blood starting to clot reoccurred. At this point, the hemodialysis machine was changed to another machine of the same make and brand. Hemodialysis was performed without further problems. The manufacturer's service technician was called in to check the affected machine. The problem could not be duplicated by the technician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1614537 |
| MDR Report Key | 1614537 |
| Date Received | 2010-02-12 |
| Date of Report | 2010-02-12 |
| Date of Event | 2010-01-26 |
| Report Date | 2010-02-12 |
| Date Reported to FDA | 2010-02-12 |
| Date Added to Maude | 2010-02-25 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | AQUARIUS |
| Generic Name | HEMODIALYSIS SYSTEM |
| Product Code | FII |
| Date Received | 2010-02-12 |
| Model Number | GEF09800 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 19 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | 1 EDWARDS WAY MAILSTOP 97 IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-12 |