Brand Name | HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR |
Type of Device | OXYGENATOR, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
SORIN GROUP ITALIA |
via statale 12 nord, 86 |
mirandola |
IT |
|
Manufacturer (Section G) |
SORIN GROUP ITALIA |
via statale 12 nord 86 |
|
mirandola |
IT
|
|
Manufacturer Contact |
cheri
voorhees, mgr
|
14401 west 65th way |
arvada, CO 80004
|
3034676527
|
|
MDR Report Key | 4170726 |
MDR Text Key | 15808659 |
Report Number | 1718850-2014-00338 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K121909 |
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 |
08/26/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/22/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/31/2014 |
Device Catalogue Number | 03708 |
Device Lot Number | 1401150085 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/26/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/01/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Weight | 80 |