Brand Name | STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP |
Type of Device | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
SORIN GROUP DEUTSCHLAND |
lindberghstr. 25 |
munich D 80 939 |
GM D 80939 |
|
Manufacturer (Section G) |
SORIN GROUP USA, INC. |
14401 west 65th way |
|
arvada CO 80004 |
|
Manufacturer Contact |
|
lindberghstr. 25 |
munich D 809-39
|
3034676527
|
|
MDR Report Key | 3883991 |
MDR Text Key | 20104646 |
Report Number | 1718850-2014-00178 |
Device Sequence Number | 1 |
Product Code |
DWA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K032213 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
05/16/2014 |
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 | 60-00-00 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/16/2014 |
Initial Date FDA Received | 06/12/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/01/2008 |
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 |