MAUDE manufacturer profile
BAXTER HEALTHCARE - LARGO · FKX
MAUDE profile for System, Peritoneal, Automatic Delivery
Key facts
| Manufacturer | BAXTER HEALTHCARE - LARGO |
|---|---|
| Manufacturer group | BAXTER HEALTHCARE - LARGO |
| Product code | FKX |
| Product code name | System, Peritoneal, Automatic Delivery |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Device Operates Differently Than Expected, Device Displays Incorrect Message, No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Improper or Incorrect Procedure or Method, No Patient Involvement, Volume Accuracy Problem Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1