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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 Dyspnea (1816); Chest Tightness/Pressure (2463)
Event Date 12/18/2017
Event Type  Injury  
Manufacturer Narrative
(b)(6). Should additional information become available, a supplemental report will be submitted.
 
Event Description
It was reported that 30 minutes after treatment with a revaclear 400/apac, the patient experienced chest tightness, coughing and difficulty breathing, associated with fever, sweating, and low blood pressure. Treatment was immediately stopped and dexamethasone 5 mg was administered intravenously. The clinical symptoms was reportedly improved. The dialyzer was replaced with an unspecified type of dialyzer. No additional information is available.
 
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. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Additional information was corrected from malfunction to serious injury event. Should additional relevant information become available, a supplemental report will be submitted.
 
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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
MDR Report Key7864763
MDR Text Key119835249
Report Number9611369-2018-00101
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K130039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2019
Device Catalogue Number114749
Device Lot Number7-7200-H-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/11/2018 Patient Sequence Number: 1
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