MARS 800473

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 2017-12-01 for MARS 800473 manufactured by Baxter Healthcare - Rostock.

Event Text Entries

[94269449] The issue occurred on an unreported date in 2017. Telephone number: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[94269450] While filling a mars kit with an unspecified solution, it was noticed that the connection of unit 4 to the blood dialyzer was partly unglued, which caused the unit to leak (no further detail was provided). The issue occurred prior to use, there was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


[115700545] Mdr 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 received for evaluation. Visual inspection revealed that the line was detached from the hansen connector at unit 4. The reported condition was verified. The cause of the condition was determined to be an insufficient gluing of the corresponding line to unit 4 during the manufacture of the set. 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 Number3007697864-2017-00069
MDR Report Key7074823
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-12-01
Date of Report2018-01-23
Date Mfgr Received2018-01-05
Date Added to Maude2017-12-01
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
Removal Correction NumberSEE H10
Event Type3
Type of Report3

Device Details

Brand NameMARS
Generic NameAPPARATUS, HEMOPERFUSION, SORBENT
Product CodeFLD
Date Received2017-12-01
Returned To Mfg2018-01-02
Model NumberNA
Catalog Number800473
Lot Number0000022763
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - ROSTOCK
Manufacturer AddressROSTOCK


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-01

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