Brand Name | HLM TUBING SET W/BIOLINE COATING |
Type of Device | TUBING, PUMP, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
MAQUET CARDIOPULMONARY AG |
rastatt |
GM |
|
Manufacturer Contact |
michael
campbell
|
kehler strasse 31 |
rastatt 76437
|
GM
76437
|
2229321132
|
|
MDR Report Key | 4259043 |
MDR Text Key | 5050683 |
Report Number | 8010762-2014-01062 |
Device Sequence Number | 1 |
Product Code |
DTL
|
Combination Product (y/n) | N |
Reporter Country Code | NL |
PMA/PMN Number | K080592 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
09/23/2014 |
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 Expiration Date | 06/01/2016 |
Device Model Number | BE-HQV 49500 |
Device Catalogue Number | 70102.5888 |
Device Lot Number | 92141520 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 09/30/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/23/2014 |
Initial Date FDA Received | 10/22/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/01/2014 |
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 |