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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 Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Chills (2191)
Event Date 10/07/2020
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient experienced chills, dyspnea, spasticity, hypertension after one hour and twenty five minutes of treatment with a polyflux 170h dialyzer. The patient was treated with methylpred (125 mg). The patient outcome was reported as improved. 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 Key11140742
MDR Text Key225814883
Report Number9611369-2020-00204
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeGM
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 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number103579
Device Lot NumberASKU
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 Received02/04/2021
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: 01/08/2021 Patient Sequence Number: 1
Treatment
NIKKISO
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