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 2020-01-13 for CLEARLINK BLOOD RECIPIENT SET 2C8750 manufactured by Baxter Healthcare Corporation.
[174884915]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[174884916]
It was reported 6 clearlink system y-type blood/solution sets when used with a baxter pump alarmed? Air-in-line?. It was further reported there was "no air in line and lines being primed and programmed correctly". The nurse attempted to? Re-prime the blood set or switch the entire tubing out completely?. The event occurred during blood transfusions. 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
[179865936]
Additional information: the actual device was not available; however, a four (4) companion samples were received for evaluation. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. The device was primed and functionally tested, and the clearlink performed according to product specifications. The reported condition was not verified. The remaining devices were not received for evaluation; therefore, a device analysis could not be completed. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2019-07540 |
| MDR Report Key | 9583017 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-13 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2019-06-11 |
| Date Added to Maude | 2020-01-13 |
| 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 - 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 | 2020-01-13 |
| Model Number | NA |
| Catalog Number | 2C8750 |
| Lot Number | DR19F10062 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-01-13 |