POLYFLUX 140H NI 955608

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 2020-03-25 for POLYFLUX 140H NI 955608 manufactured by Baxter Healthcare - Hechingen Baden Dialyzer.

Event Text Entries

[185296132] The device was received for evaluation. A leakage test on the dialysate side was performed and a crack in the welding zone was found. The failure could be confirmed. The review of the welding parameters of the product showed no conspicuousness, they were within the specification. The cause was undetermined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[185296133] It was reported that ten minutes after starting treatment with a polyflux 140h, an external dialysate leakage was observed between the header and the housing. 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 Number9611369-2020-00026
MDR Report Key9878442
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-02-29
Date Mfgr Received2020-02-29
Date Added to Maude2020-03-25
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 - HECHINGEN BADEN DIALYZER
Manufacturer StreetHOLGER - CRAFOORD - STRASSE 26
Manufacturer CityHECHINGEN D-72379
Manufacturer CountryGM
Manufacturer Postal CodeD-72379
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLYFLUX 140H
Generic NameDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Product CodeKDI
Date Received2020-03-25
Returned To Mfg2020-03-20
Model NumberNI
Catalog Number955608
Lot Number9-5501-H-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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