MAUDE manufacturer profile
FRESENIUS KABI USA, LLC · PHC
MAUDE profile for Infusion Safety Management Software
Key facts
| Manufacturer | FRESENIUS KABI USA, LLC |
|---|---|
| Manufacturer group | FRESENIUS KABI USA, LLC |
| Product code | PHC |
| Product code name | Infusion Safety Management Software |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Apparent Adverse Event, No Clinical Signs, Symptoms or Conditions, Computer Software Problem, Infusion or Flow Problem, Insufficient Flow or Under 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