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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 955609
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Anxiety (2328)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
Initial reporter phone number: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that approximately ten to fifteen minutes after starting treatment with one unit of polyflux 170h, a patient experienced a drop in blood pressure from 150 mmhg to 100 mmhg. The patient also experienced dysphoria, abdominal discomfort and fecal incontinence. Treatment was stopped and the blood pressure recovered to 130 mmhg ten minutes later. Dialysis treatment was completed successfully. 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 Key10946239
MDR Text Key219523352
Report Number9611369-2020-00178
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeJA
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
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number955609
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 Received11/09/2020
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: 12/04/2020 Patient Sequence Number: 1
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