Brand Name | AFFINITY HFO W/TRILLIUM 511T |
Type of Device | OXYGENATOR, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
PERFUSION SYSTEMS |
7611 northland dr |
brooklyn park MN 55428 |
|
Manufacturer (Section G) |
PERFUSION SYSTEMS |
7611 northland dr |
|
brooklyn park MN 55428 |
|
Manufacturer Contact |
alison
sweeney
|
parkmore business park west |
galway
|
EI
|
091708096
|
|
MDR Report Key | 13786748 |
MDR Text Key | 289269826 |
Report Number | 2184009-2022-00032 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K191029 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/16/2022 |
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 | 07/28/2022 |
Device Model Number | 95215 |
Device Catalogue Number | 95215 |
Device Lot Number | 13366463 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/17/2022
|
Initial Date FDA Received | 03/16/2022 |
Date Device Manufactured | 01/28/2021 |
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 |