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 2019-02-17 for MARS 800541 manufactured by Baxter Healthcare - Rostock.

Event Text Entries

[139604804] Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[139604806] It was reported that a leak was observed on a mars disposable at the 'truckler filter' during patient treatment. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007697864-2019-00001
MDR Report Key8346624
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-02-17
Date of Report2019-03-12
Date of Event2018-12-23
Date Facility Aware2019-01-23
Report Date2019-02-17
Date Reported to FDA2019-02-17
Date Reported to Mfgr2019-02-17
Date Mfgr Received2019-03-11
Date Added to Maude2019-02-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 Phone2242702068
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 NameAPPARATUS, HEMOPERFUSION, SORBENT
Product CodeFLD
Date Received2019-02-17
Model NumberNA
Catalog Number800541
Lot Number17F1905
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - ROSTOCK
Manufacturer AddressROSTOCK


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-17

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