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 2020-03-30 for CLEARLINK BLOOD RECIPIENT SET 4C8723 manufactured by Baxter Healthcare Corporation.
[185519136]
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185519137]
It was reported that two units of access blood solution sets leaked during patient use. The leaks were observed at the side of the pressure pump chamber of the sets while the patient was connected. It was reported the patient was on the way to the intensive care unit and? Eventually passed away?. The cause of death was unknown. It was not reported if an autopsy was performed. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01818 |
| MDR Report Key | 9897813 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-11-27 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 - CARTAGO |
| Manufacturer Street | SEE H10 SEE H10 |
| Manufacturer City | CARTAGO 30106 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 30106 |
| 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 | 2020-03-30 |
| Model Number | NA |
| Catalog Number | 4C8723 |
| Lot Number | R19K23082 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Death | 2020-03-30 |