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 |
|
Manufacturer (Section G) |
THORATEC SWITZERLAND GMBH |
technoparkstrasse 1 |
|
zurich CH-80 05 |
SZ
CH-8005
|
|
Manufacturer Contact |
bob
fryc
|
6035 stoneridge drive |
pleasanton, CA 94588
|
7818528204
|
|
MDR Report Key | 8479529 |
MDR Text Key | 140804875 |
Report Number | 2916596-2019-01350 |
Device Sequence Number | 1 |
Product Code |
KFM
|
UDI-Device Identifier | 07640135140078 |
UDI-Public | 07640135140078 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup,Followup |
Report Date |
06/09/2021 |
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 | 03/27/2019 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/18/2019 |
Initial Date FDA Received | 04/03/2019 |
Supplement Dates Manufacturer Received | 08/29/2019 06/09/2021
|
Supplement Dates FDA Received | 08/30/2019 06/09/2021
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/18/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | FA-Q318-MCS-1 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 54 YR |
Patient Weight | 136 |
|
|