MAUDE manufacturer profile
ICU MEDICAL COSTA RICA LTD. · FRN
MAUDE profile for Pump, Infusion
Key facts
| Manufacturer | ICU MEDICAL COSTA RICA LTD. |
|---|---|
| Manufacturer group | ICU MEDICAL COSTA RICA LTD. |
| Product code | FRN |
| Product code name | Pump, Infusion |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Unexpected Shutdown, Inaccurate Delivery, Infusion or Flow Problem, No Consequences Or Impact To Patient, Excess Flow or Over-Infusion, Inaccurate Flow Rate, Battery 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