MAUDE manufacturer profile
THORATEC CORP. · KFM
MAUDE profile for Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Key facts
| Manufacturer | THORATEC CORP. |
|---|---|
| Manufacturer group | THORATEC CORP. |
| Product code | KFM |
| Product code name | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Insufficient Information, Mechanical Problem, Multiple Organ Dysfunction Syndrome, Infusion or Flow Problem, Unexpected Shutdown, 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