Brand Name | SORIN 3T HEATER COOLER (NOW LINOVA) |
Type of Device | CONTROLLER, TEMPERATURE, CADIOPULMNARY BYPASS |
Manufacturer (Section D) |
SORIN GROUP USA, INC. / LIVANOVA USA, INC. |
arvado CO |
|
MDR Report Key | 8208310 |
MDR Text Key | 131901042 |
Report Number | MW5082707 |
Device Sequence Number | 1 |
Product Code |
DWC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Unknown
|
Type of Report
| Initial |
Report Date |
12/20/2018 |
4 Devices were Involved in the Event: |
1
2
3
4
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/31/2018 |
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
Patient Age | 70 YR |
|
|