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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER 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 Chest Pain (1776); Low Blood Pressure/ Hypotension (1914)
Event Date 06/25/2018
Event Type  Injury  
Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. The cause of the condition could not be determined. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient experienced chest pain and hypotension approximately ten minutes after treatment started with a revaclear 400. The patient had six treatments using a revaclear 400 leading to the physician deciding to switch back to the original prescription of fx80 cordiax with no further symptoms noted. No medical intervention was reported. 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 - 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 Key7709812
MDR Text Key114679014
Report Number9611369-2018-00072
Device Sequence Number1
Product Code KDI
UDI-Device Identifier07332414114954
UDI-Public(01)07332414114954
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 07/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2020
Device Catalogue Number114749
Device Lot Number7-7204-H-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
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

Patient Treatment Data
Date Received: 07/23/2018 Patient Sequence Number: 1
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