Brand Name | CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS |
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 |
|
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 | 9849283 |
MDR Text Key | 189324097 |
Report Number | 3003306248-2020-00010 |
Device Sequence Number | 1 |
Product Code |
KFM
|
UDI-Device Identifier | 7640135140030 |
UDI-Public | (01)7640135140030(10)L06322-LA4 |
Combination Product (y/n) | N |
Reporter Country Code | TW |
PMA/PMN Number | K020271 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/18/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2022 |
Device Model Number | 201-90010 |
Device Lot Number | L06322-LA4 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/18/2020 |
Initial Date FDA Received | 03/18/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/28/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 45 YR |
Patient Weight | 54 |