Brand Name | ADVANCED PERFUSION SYSTEM 1 |
Type of Device | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 |
Manufacturer (Section D) |
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
6200 jackson road |
ann arbor MI 48103 |
|
Manufacturer Contact |
eileen
dorsey
|
6200 jackson road |
ann arbor, MI 48103
|
7346634145
|
|
MDR Report Key | 7133234 |
MDR Text Key | 95814783 |
Report Number | 1828100-2017-00584 |
Device Sequence Number | 1 |
Product Code |
DTQ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K153376 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
04/06/2018 |
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 | 801763 |
Device Catalogue Number | 801763 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/18/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/04/2017
|
Initial Date FDA Received | 12/20/2017 |
Supplement Dates Manufacturer Received | 12/18/2017 02/08/2018 04/05/2018
|
Supplement Dates FDA Received | 01/12/2018 03/05/2018 04/06/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/18/2006 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |