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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 14L DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION POLYFLUX 14L DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 109651
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone number: (b)(6). The device was not received for evaluation, however two pictures was received. The visual inspection of the provided photos showed the product after treatment. The photo showed blood outside the product. The reported condition was verified. The cause could not be determined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that 30 minutes after starting treatment with a polyflux 14l dialyzer, an external blood leak was observed. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NamePOLYFLUX 14L
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 Key11309201
MDR Text Key250898740
Report Number9611369-2021-00018
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCH
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number109651
Device Lot Number0-5149-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 Received01/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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