Brand Name | CUSTOM PERFUSION TUBING SET |
Type of Device | CARDIOPULMONARY BYPASS CUSTOM TUBING KIT |
Manufacturer (Section D) |
LIVANOVA USA, INC. |
14401 w 65th way |
arvada CO 80004 |
|
Manufacturer (Section G) |
LIVANOVA USA, INC. |
14401 w 65th way |
|
arvada CO 80004 |
|
Manufacturer Contact |
njemile
crawley
|
14401 w 65th way |
arvada, CO 80004
|
2812287575
|
|
MDR Report Key | 8240375 |
MDR Text Key | 132926472 |
Report Number | 1718850-2019-00001 |
Device Sequence Number | 1 |
Product Code |
DWE
|
UDI-Device Identifier | 00803622126475 |
UDI-Public | (01)00803622126475(240)627331801(17)200731(10)1821200057 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K981613 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
04/26/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/11/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/31/2020 |
Device Catalogue Number | 627331801 |
Device Lot Number | 1821200057 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/10/2019 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 03/29/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/31/2018 |
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 |