Brand Name | CLEARLINK SYSTEM Y TYPE BLOOD/SOLUTION SET |
Type of Device | SET, BLOOD TRANSFUSION |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
25212 w. illinois route 120 |
round lake IL 60073 |
|
MDR Report Key | 9853083 |
MDR Text Key | 184068948 |
Report Number | 9853083 |
Device Sequence Number | 1 |
Product Code |
BRZ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/03/2020,02/12/2020 |
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 |
No Information
|
Device Model Number | 2C8750 |
Device Catalogue Number | 2C8750 S |
Device Lot Number | DR19K11038 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/03/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/19/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/19/2020 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|