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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 17L DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 17L DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 102058
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperventilation (1910); Rash (2033); Swelling (2091)
Event Date 04/12/2018
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during treatment with a polyflux 17l dialyzer, the patient presented allergic reactions (drop in blood pressure, rash, swelling at the neck, breathlessness). No other baxter products (machine or solutions) were being used at the time of the event. Further treatment information was not provided. The outcome of the patient was not reported. No additional information is available.
 
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Brand NamePOLYFLUX 17L
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
hechingen
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 Key7487282
MDR Text Key107377371
Report Number9611369-2018-00049
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
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 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2020
Device Catalogue Number102058
Device Lot Number8-4301-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 Received05/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/04/2018 Patient Sequence Number: 1
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