Brand Name | SORIN 3T PERFUSION HEATER-COOLER |
Type of Device | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
LIVANOVA (FORMERLY SORIN GROUP, S.P.A) |
via benigono crespi, 17 |
milano 20159 |
IT 20159 |
|
MDR Report Key | 5764537 |
MDR Text Key | 48629184 |
Report Number | MW5063181 |
Device Sequence Number | 0 |
Product Code |
DWC
|
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
06/22/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 3T |
Device Catalogue Number | 16-02-85 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 06/29/2016 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|