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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION POLYFLUX 170H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 103579
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Palpitations (2467)
Event Date 06/15/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that after 10 minutes of starting treatment with a polyflux 170h dialyzer, the patient experienced shortness of breath, palpitations and nausea. Treatment was discontinued. It was reported the patient¿s ¿symptoms settled after 10-15 minutes¿. There was no report of any medical intervention associated with this event. It was reported this was a first time use with the polyflux dialyzer. 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 CORPORATION
deerfield IL
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 Key10257682
MDR Text Key199894121
Report Number9611369-2020-00084
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
K043342
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number103579
Device Lot Number0-4716-H-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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