MAUDE manufacturer profile
THORATEC SWITZERLAND GMBH · KFM
MAUDE profile for Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Key facts
| Manufacturer | THORATEC SWITZERLAND GMBH |
|---|---|
| Manufacturer group | THORATEC SWITZERLAND GMBH |
| Product code | KFM |
| Product code name | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Insufficient Information, Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Mechanical Problem, No Consequences Or Impact To Patient, Infusion or Flow Problem, Noise, Audible 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