MAUDE manufacturer profile
ABIOMED, INC. · KFM
MAUDE profile for Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Key facts
| Manufacturer | ABIOMED, INC. |
|---|---|
| Manufacturer group | ABIOMED, INC. |
| Product code | KFM |
| Product code name | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Device Displays Incorrect Message, Device Operates Differently Than Expected, Death, No Information, Low Blood Pressure/ Hypotension, Adverse Event Without Identified Device or Use Problem, Difficult to Insert 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