MAUDE manufacturer profile
SORIN GROUP ITALIA · DTN
MAUDE profile for Reservoir, Blood, Cardiopulmonary Bypass
Key facts
| Manufacturer | SORIN GROUP ITALIA |
|---|---|
| Manufacturer group | SORIN GROUP ITALIA |
| Product code | DTN |
| Product code name | Reservoir, Blood, Cardiopulmonary Bypass |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, Air/Gas in Device, No Clinical Signs, Symptoms or Conditions, Gas/Air Leak, Infusion or Flow Problem, Disconnection, Detachment Of Device Component, No Consequences Or Impact To Patient 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