MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for CLEARLINK BLOOD RECIPIENT SET 2C8750 manufactured by Baxter Healthcare Corporation.
[185260028]
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185260029]
It was reported that a clearlink system y-type blood/solution set was leaking at the bottom of the filter chamber. The leak was identified while priming. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1416980-2020-01787 |
MDR Report Key | 9889414 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-03-27 |
Date of Report | 2020-03-27 |
Date of Event | 2020-03-02 |
Date Mfgr Received | 2020-03-04 |
Date Added to Maude | 2020-03-27 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
Manufacturer City | ROUND LAKE IL 60073 |
Manufacturer Country | US |
Manufacturer Postal | 60073 |
Manufacturer Phone | 2242702068 |
Manufacturer G1 | BAXTER HEALTHCARE - DOMINICAN REPUBLIC |
Manufacturer Street | CARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO, PIISA |
Manufacturer City | HAINA, SAN CRISTOBAL |
Manufacturer Country | DR |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CLEARLINK BLOOD RECIPIENT SET |
Generic Name | SET, BLOOD TRANSFUSION |
Product Code | BRZ |
Date Received | 2020-03-27 |
Model Number | NA |
Catalog Number | 2C8750 |
Lot Number | ASKU |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BAXTER HEALTHCARE CORPORATION |
Manufacturer Address | DEERFIELD IL |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-27 |