MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-02-26 for CLEARLINK BLOOD RECIPIENT SET 2C8750 manufactured by Baxter Healthcare Corporation.
[180868383]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[180868384]
It was reported that two clearlink system y-type blood/solution sets were leaking. After 5 minutes of platelet infusion, the set was observed to be leaking at the distal end of the tubing just above the luer lock. The customer attempted to resolve the issue by replacing the set and spiking a second bag of platelets; however, the leak was observed again at the distal end of the tubing just above the luer lock. The platelet transfusion was completed without difficulty after the set was changed again. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-00966 |
| MDR Report Key | 9753279 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-02-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2019-10-16 |
| Date Added to Maude | 2020-02-26 |
| 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 | 2020-02-26 |
| Returned To Mfg | 2020-03-05 |
| Model Number | NA |
| Catalog Number | 2C8750 |
| Lot Number | DR19J15023 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |