MAUDE manufacturer profile
SORIN GROUP DEUTSCHLAND · DWB
MAUDE profile for Pump, Blood, Cardiopulmonary Bypass, Roller Type
Key facts
| Manufacturer | SORIN GROUP DEUTSCHLAND |
|---|---|
| Manufacturer group | LIVANOVA DEUTSCHLAND |
| Product code | DWB |
| Product code name | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, No Consequences Or Impact To Patient, No Display/Image, Device Displays Incorrect Message, Pumping Stopped, Device Operational Issue, Failure to Pump, Detachment Of Device Component 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