MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for CLEARLINK SYSTEM Y TYPE BLOOD/SOLUTION SET 2C8750 2C8750 S manufactured by Baxter Healthcare Corporation.
[184068948]
The blood product had a hole and leaked at the bottom of the filter chamber and there was a crack in the filter chamber as well.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9853083 |
MDR Report Key | 9853083 |
Date Received | 2020-03-19 |
Date of Report | 2020-02-12 |
Date of Event | 2020-02-12 |
Report Date | 2020-03-03 |
Date Reported to FDA | 2020-03-03 |
Date Reported to Mfgr | 2020-03-19 |
Date Added to Maude | 2020-03-19 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CLEARLINK SYSTEM Y TYPE BLOOD/SOLUTION SET |
Generic Name | SET, BLOOD TRANSFUSION |
Product Code | BRZ |
Date Received | 2020-03-19 |
Model Number | 2C8750 |
Catalog Number | 2C8750 S |
Lot Number | DR19K11038 |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BAXTER HEALTHCARE CORPORATION |
Manufacturer Address | 25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US 60073 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-19 |