MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-07 for CLEARLINK BLOOD RECIPIENT SET 2C8720 manufactured by Baxter Healthcare Corporation.
[174131311]
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[174131312]
It was reported that an unspecified quantity of clearlink system y-type blood/solution sets were leaking "at the connection" during a blood transfusion. This issue was identified when the blood transfusion was almost complete. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[179669071]
The actual device was not available; however, a photograph of the sample was provided for evaluation. A visual inspection was performed to the photograph, using the naked eye, which did not identify any abnormalities that could have contributed to the reported condition. The reported condition was not clearly observed via the photograph provided. Therefore, the reported condition was not verified. Due to the nature of the sample, no additional testing could be performed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2019-07437 |
| MDR Report Key | 9559199 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-07 |
| Date of Report | 2020-02-12 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-01-07 |
| 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 - 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 | 2020-01-07 |
| Model Number | NA |
| Catalog Number | 2C8720 |
| Lot Number | ASKU |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |