Brand Name | CLEARLINK BLOOD RECIPIENT SET |
Type of Device | SET, BLOOD TRANSFUSION |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - DOMINICAN REPUBLIC |
carretera sanchez km 18.5 |
parque industrial itabo, piisa |
haina, san cristobal 91000 |
DR
91000
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 16265233 |
MDR Text Key | 308468676 |
Report Number | 1416980-2023-00192 |
Device Sequence Number | 1 |
Product Code |
BRZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K993120 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
01/30/2023 |
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 Catalogue Number | 2C8750 |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/05/2023 |
Initial Date FDA Received | 01/30/2023 |
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 |
Treatment | CELLS; KELLY CLAMPS; NON-BAXTER CATHETER |
Patient Age | 54 YR |
Patient Sex | Female |
Patient Weight | 65 KG |
Patient Race | White |
|
|