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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 114749
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Chills (2191)
Event Date 03/23/2021
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that after 30 minutes of treatment with a revaclear 400, a patient experienced chill and nausea. The patient was treated with dexamethasone and the symptoms 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 - HECHINGEN BADEN DIALYZER
holger - crafoord - strasse 26
hechingen D-723 79
GM D-72379
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key11811756
MDR Text Key250187381
Report Number9611369-2021-00086
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,Followup
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114749
Device Lot Number0-9732-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 Received05/19/2021
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 Unkown

Patient Treatment Data
Date Received: 05/12/2021 Patient Sequence Number: 1
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