Brand Name | SORIN CENTRIFUGAL PUMP 5 (CP5) |
Type of Device | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
SORIN GROUP DEUTSCHLAND |
lindberghstr. 25 |
munich, |
|
Manufacturer (Section G) |
SORIN GROUP DEUTSCHLAND |
lindberghstr. 25 |
|
munich, 80939 |
GM
80939
|
|
Manufacturer Contact |
carrie
wood
|
14401 w. 65th way |
arvada, CO 80004
|
3034676461
|
|
MDR Report Key | 5408877 |
MDR Text Key | 37721909 |
Report Number | 9611109-2016-00007 |
Device Sequence Number | 1 |
Product Code |
DWA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K112225 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Health Professional
|
Remedial Action |
Other |
Type of Report
| Initial,Followup,Followup |
Report Date |
01/05/2016 |
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 | 60-02-60 |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/05/2016 |
Initial Date FDA Received | 02/03/2016 |
Supplement Dates Manufacturer Received | 05/01/2016 05/01/2016
|
Supplement Dates FDA Received | 02/18/2021 05/03/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/15/2013 |
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 |
|
|