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 |