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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 140H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION POLYFLUX 140H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 103530
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
The device has been received and the evaluation is in progress. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during treatment with a polyflux 140h, an external dialysate leak occurred and an ungluing was observed at the header. It was reported that there was massive dripping of dialysate and "uncontrolled dehydration". A "dialysate circuit leaking" was triggered by the control unit. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NamePOLYFLUX 140H
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
ni
hechingen D-723 79
GM D-72379
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key11387898
MDR Text Key250897845
Report Number9611369-2021-00030
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 03/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number103530
Device Lot Number0-5719-H-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2021
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

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