MAUDE manufacturer profile
SORIN GROUP ITALIA S.R.L. · DTR
MAUDE profile for Heat-Exchanger, Cardiopulmonary Bypass
Key facts
| Manufacturer | SORIN GROUP ITALIA S.R.L. |
|---|---|
| Manufacturer group | SORIN GROUP ITALIA |
| Product code | DTR |
| Product code name | Heat-Exchanger, Cardiopulmonary Bypass |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, No Patient Involvement, No Clinical Signs, Symptoms or Conditions, Other (for use when an appropriate device code cannot be identified), Air Leak, Fluid/Blood Leak, Air/Gas in Device, Device Contamination with Chemical or Other Material 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