MARS 800540

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-08 for MARS 800540 manufactured by Baxter Healthcare - Rostock.

Event Text Entries

[99930190] Concomitant medical products: therapy dates - event occurred in (b)(6) 2017. (b)(6). Correction/removal report number: 3007697864-12/12/2017-001-r. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[99930191] It was reported that a leakage occurred in the albumin circuit of a mars treatment kit during priming. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007697864-2018-00002
MDR Report Key7256530
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-02-08
Date of Report2018-02-08
Date Facility Aware2018-01-16
Date Mfgr Received2018-01-16
Date Added to Maude2018-02-08
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
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMARS
Generic NameAPPARATUS, HEMOPERFUSION, SORBENT
Product CodeFLD
Date Received2018-02-08
Model NumberNA
Catalog Number800540
Lot Number0000022651
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - ROSTOCK
Manufacturer AddressROSTOCK


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-08

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