MARS 800541

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number3006552611-2020-00003
MDR Report Key9845123
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2020-01-13
Date Facility Aware2020-02-18
Report Date2020-03-17
Date Reported to FDA2020-03-17
Date Reported to Mfgr2020-03-17
Date Mfgr Received2020-02-18
Date Added to Maude2020-03-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer G1BAXTER HEALTHCARE - ROSTOCK
Manufacturer StreetFRIEDRICH-BARNEWITZ-STRASSE 4
Manufacturer CityROSTOCK 18119
Manufacturer CountryGM
Manufacturer Postal Code18119
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMARS
Generic NameMARS KIT GAMBRO, TYPE 1116/1
Product CodeFLD
Date Received2020-03-17
Model NumberNA
Catalog Number800541
Lot Number0000024650
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.