MAUDE manufacturer profile
CME AMERICA LLC · FRN
MAUDE profile for Pump, Infusion
Key facts
| Manufacturer | CME AMERICA LLC |
|---|---|
| Manufacturer group | CME AMERICA LLC |
| Product code | FRN |
| Product code name | Pump, Infusion |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Use of Device Problem, No Patient Involvement, Device Displays Incorrect Message, No Consequences Or Impact To Patient, Increased Pump Speed, Device Operates Differently Than Expected, Excess Flow or Over-Infusion 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