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 2020-02-01 for SET, BLOOD TRANSFUSION manufactured by Baxter Healthcare Corporation.
[177356890]
(b)(6). 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
[177356891]
It was reported that an unspecified quantity of blood solution sets underinfused during patient infusions. This was identified while in use with an infusion pump and further described as? The infusion pump prolongs the infusion by an additional 30 minutes?. 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
| Report Number | 1416980-2020-00353 |
| MDR Report Key | 9656425 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-01 |
| Date of Report | 2020-01-31 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-02-01 |
| 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 | PHARMACIST |
| 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 CORPORATION |
| Manufacturer Street | NI NI |
| Manufacturer City | NI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | SET, BLOOD TRANSFUSION |
| Product Code | BRZ |
| Date Received | 2020-02-01 |
| Model Number | NA |
| Catalog Number | ASKU |
| 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 | 2020-02-01 |