MAUDE manufacturer profile
SORIN GROUP ITALIA SRL · DTZ
MAUDE profile for Oxygenator, Cardiopulmonary Bypass
Key facts
| Manufacturer | SORIN GROUP ITALIA SRL |
|---|---|
| Manufacturer group | SORIN GROUP ITALIA SRL |
| Product code | DTZ |
| Product code name | Oxygenator, Cardiopulmonary Bypass |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Fluid/Blood Leak, Increase in Pressure, Unexpected Therapeutic Results, No Patient Involvement, Pressure Problem, Leak/Splash 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