Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Manufacturer Narrative
Additional information added to h6 and h10.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POLYFLUX 170H
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11140742
MDR Text Key225814883
Report Number9611369-2020-00204
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
PMA/PMN Number
K043342
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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 Health Professional
Device Catalogue Number103579
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NIKKISO; NIKKISO
Patient Outcome(s) Required Intervention;
-
-