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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REVACLEAR 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION REVACLEAR 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 114746L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Glossitis (4490)
Event Date 07/12/2021
Event Type  Injury  
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that towards the end of treatment with a revaclear 400 dialyzer, a patient experienced rash and felt their tongue thicken. The patient injected themselves with an epipen and discontinued dialysis treatment. It was reported that the patient presented to the hospital. At the time of this report, the symptoms had improved. No additional information is available.
 
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Brand NameREVACLEAR 400
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - OPELIKA
1101 jeter ave
opelika AL 36801
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12287520
MDR Text Key265376691
Report Number3006552611-2021-00010
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K130039
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 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114746L
Device Lot NumberC621403305
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 Received08/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/06/2021 Patient Sequence Number: 1
Treatment
CHLORINEXIDINE; NOVALINE BL102; OPTIFLUS 220
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