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 (Section G) |
|
Manufacturer Contact |
douglas
patton
|
6200 jackson road |
ann arbor, MI 48103
|
7346634145
|
|
MDR Report Key | 18529024 |
MDR Text Key | 333347057 |
Report Number | 1828100-2024-00018 |
Device Sequence Number | 1 |
Product Code |
DTQ
|
UDI-Device Identifier | 00886799000588 |
UDI-Public | (01)00886799000588(11)220301 |
Combination Product (y/n) | N |
Reporter Country Code | MX |
PMA/PMN Number | K022947 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
03/28/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/17/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 801188 |
Device Catalogue Number | 801188 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 03/05/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 03/01/2022 |
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 |