MAUDE manufacturer profile
SORIN GROUP DEUTSCHLAND · DTQ
MAUDE profile for Console, Heart-Lung Machine, Cardiopulmonary Bypass
Key facts
| Manufacturer | SORIN GROUP DEUTSCHLAND |
|---|---|
| Manufacturer group | SORIN GROUP DEUTSCHLAND |
| Product code | DTQ |
| Product code name | Console, Heart-Lung Machine, Cardiopulmonary Bypass |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Other (for use when an appropriate device code cannot be identified), No Consequences Or Impact To Patient, No Patient involvement, No Patient Involvement, Device Displays Incorrect Message, Pumping Stopped, Device Operational Issue, No Display/Image 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