Brand Name | TERUMO CENTRIFUGAL SYSTEM |
Type of Device | SARNS CENTRIFUGAL SYSTEM |
Manufacturer (Section D) |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
ann arbor MI 48103 |
|
Manufacturer Contact |
jan
winder
|
6200 jackson rd. |
ann arbor, MI 48103
|
7346634145
|
|
MDR Report Key | 4597326 |
MDR Text Key | 5627918 |
Report Number | 1828100-2015-00207 |
Device Sequence Number | 1 |
Product Code |
DWA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K950739 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/11/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/05/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 164267 |
Device Catalogue Number | 164267 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 02/13/2015 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/11/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/01/2004 |
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 |
|
|