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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 112466
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Low Blood Pressure/ Hypotension (1914); Sweating (2444)
Event Type  Injury  
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient being treated with a polyflux 170h dialyzer, experienced abdominal pain (described as similar to premenstrual syndrome abdominal cramp), sweating and a drop in blood pressure. The patient was treated with an unspecified antihistamine, but the symptoms persisted. It was reported that after blood return was performed, the patient was switched to a different dialyzer brand, and the symptoms resolved. There was no patient injury or medical intervention associated with this event. 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 Key10277083
MDR Text Key199074604
Report Number9611369-2020-00087
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeTH
PMA/PMN Number
NI
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
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2020
Device Catalogue Number112466
Device Lot Number7-4505-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 Received07/28/2020
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

Patient Treatment Data
Date Received: 07/15/2020 Patient Sequence Number: 1
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