Brand Name | CENTRIMAG 2ND GENERATION PRIMARY CONSOLE |
Type of Device | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
THORATEC SWITZERLAND GMBH |
technoparkstrasse 1 |
zurich CH-80 05 |
SZ CH-8005 |
|
Manufacturer (Section G) |
THORATEC SWITZERLAND GMBH |
technoparkstrasse 1 |
|
zurich CH-80 05 |
SZ
CH-8005
|
|
Manufacturer Contact |
lindsey
sallese
|
6035 stoneridge drive |
pleasanton, CA 94588
|
7818528207
|
|
MDR Report Key | 19140314 |
MDR Text Key | 340682572 |
Report Number | 3003306248-2024-00474 |
Device Sequence Number | 1 |
Product Code |
DWA
|
UDI-Device Identifier | 07640135140702 |
UDI-Public | (01)07640135140702(10)6955545(17)210430 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K131179 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/15/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2021 |
Device Model Number | 201-90411 |
Device Lot Number | 6955545 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/04/2024
|
Initial Date FDA Received | 04/18/2024 |
Supplement Dates Manufacturer Received | 04/22/2024
|
Supplement Dates FDA Received | 05/15/2024
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Age | 5 YR |
Patient Sex | Male |
Patient Weight | 22 KG |