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 2017-10-13 for MARS 800541 manufactured by Baxter Healthcare - Rostock.

Event Text Entries

[90312193] Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[90312194] During priming of the mars device, the user noticed a leak in the tubing set at the connection site to the mars filter. The user was not able to complete the priming set up. The user took the whole set down and used another new set for priming and patient treatment. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


[115701404] Additional information: lot number. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The actual device was not received for evaluation; however, a video and photos were provided. The visual inspection of the provided photos and video confirms the failure description of the user. The disconnection between hansen connector and corresponding line is clearly visible and caused by an insufficient gluing. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3007697864-2017-00058
MDR Report Key6950112
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-10-13
Date of Report2017-11-21
Date of Event2017-09-17
Date Facility Aware2017-09-19
Report Date2017-10-13
Date Reported to FDA2017-10-13
Date Reported to Mfgr2017-10-13
Date Mfgr Received2017-11-17
Date Added to Maude2017-10-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 Received2017-10-13
Model NumberNA
Catalog Number800541
Lot Number0000022597
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - ROSTOCK
Manufacturer AddressROSTOCK


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-13

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