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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 170H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 170H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 103579
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 12/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during priming of a polyflux 170h dialyzer, black particles were observed inside the filter ¿on the blood side of the dialyzer¿. No particles were observed in the set. The set and filter were changed prior to starting treatment. There was no patient involvement. No additional information is available.
 
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Brand NamePOLYFLUX 170H
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
hechingen
Manufacturer (Section G)
BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
holger - crafoord - strasse 26
hechingen D-723 79
GM D-72379
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8200674
MDR Text Key132505003
Report Number9611369-2018-00154
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K043342
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Catalogue Number103579
Device Lot Number8-4741-H-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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