Brand Name | CENTRIMAG MOTOR, US |
Type of Device | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
Manufacturer (Section D) |
THORATEC SWITZERLAND GMBH |
technoparkstrasse 1 |
zurich CH-80 05 |
SZ CH-8005 |
|
MDR Report Key | 9514508 |
MDR Text Key | 173687343 |
Report Number | 2916596-2019-05890 |
Device Sequence Number | 1 |
Product Code |
KFM
|
UDI-Device Identifier | 07640135140078 |
UDI-Public | 07640135140078 |
Combination Product (y/n) | N |
PMA/PMN Number | K020271 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
03/13/2020 |
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? |
Yes
|
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 | 10/24/2019 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/11/2019 |
Initial Date FDA Received | 12/24/2019 |
Supplement Dates Manufacturer Received | 03/09/2020
|
Supplement Dates FDA Received | 03/13/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Removal/Correction Number | Z-0103-2019 |
Patient Sequence Number | 1 |
|
|