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 2020-03-17 for MARS 800541 manufactured by Baxter Healthcare Corporation.
[183874230]
This report was received from medwatch report: (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[183874231]
It was reported that upon initiation of therapy with a mars kit, a pink tinge was observed in the albumin. The pink tinge was a result of a blood leak into the albumin circuit. A blood leak alarm was triggered. The therapy was immediately stopped, however, the blood was not returned to the patient. The patient was transfused with 2 units of packed red blood cells, due to a drop in hemoglobin "below critical care standards" and the loss of blood in the mars set. The patient outcome was not reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006552611-2020-00003 |
| MDR Report Key | 9845123 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-01-13 |
| Date Facility Aware | 2020-02-18 |
| Report Date | 2020-03-17 |
| Date Reported to FDA | 2020-03-17 |
| Date Reported to Mfgr | 2020-03-17 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-17 |
| 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 | RISK MANAGER |
| 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 G1 | BAXTER HEALTHCARE - ROSTOCK |
| Manufacturer Street | FRIEDRICH-BARNEWITZ-STRASSE 4 |
| Manufacturer City | ROSTOCK 18119 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 18119 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARS |
| Generic Name | MARS KIT GAMBRO, TYPE 1116/1 |
| Product Code | FLD |
| Date Received | 2020-03-17 |
| Model Number | NA |
| Catalog Number | 800541 |
| Lot Number | 0000024650 |
| 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. Required No Informationntervention | 2020-03-17 |