Brand Name | QUART ARTERIAL FILTER, MODEL HBF 140 |
Type of Device | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
Manufacturer (Section D) |
MAQUET CARDIOPULMONARY AG |
rastatt |
GM |
|
MDR Report Key | 8005452 |
MDR Text Key | 125140152 |
Report Number | 8010762-2018-00289 |
Device Sequence Number | 1 |
Product Code |
DTM
|
Combination Product (y/n) | N |
PMA/PMN Number | K001787 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup |
Report Date |
12/13/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/25/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/31/2019 |
Device Model Number | 00175 QUART |
Device Catalogue Number | 700000175 |
Device Lot Number | 70116051 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/07/2018 |
Date Manufacturer Received | 10/17/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|