Brand Name | CENTRIMAG MOTOR, US |
Type of Device | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
Manufacturer (Section D) |
THORATEC SWITZERLAND GMBH |
technoparkstrasse 1 |
zurich CA CH-80 05 |
SZ CH-8005 |
|
MDR Report Key | 8307705 |
MDR Text Key | 137024028 |
Report Number | 2916596-2019-00392 |
Device Sequence Number | 1 |
Product Code |
KFM
|
UDI-Device Identifier | 07640135140078 |
UDI-Public | 07640135140078 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Type of Report
| Initial,Followup,Followup |
Report Date |
02/27/2020 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 102956 |
Device Catalogue Number | 102956 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/28/2019 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/22/2019 |
Initial Date FDA Received | 02/05/2019 |
Supplement Dates Manufacturer Received | 05/20/2019 02/10/2020
|
Supplement Dates FDA Received | 05/22/2019 02/27/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|