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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER THERANOVA 500 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER THERANOVA 500 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 115579
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Edema (1820)
Event Date 08/20/2019
Event Type  Injury  
Manufacturer Narrative
The patient was born on an unspecified date in (b)(6). 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.
 
Event Description
It was reported that 12 hours after treatment ended with a theranova 500 dialyzer, the patient experienced angioedema, left hemi-language edema, mucosal edema, buccal edema, and dyspnea. The patient presented to the emergency department and was treated with intravenous urbason and polaramine. It was reported the symptoms ¿disappeared¿ and the patient was recovered from the events. At the time of this report, the patient receives treatment with a non-baxter dialyzer. No additional information is available.
 
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Brand NameTHERANOVA 500
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 Key9076274
MDR Text Key163065932
Report Number9611369-2019-00142
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number115579
Device Lot Number9-6806-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 Received08/22/2019
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: 09/17/2019 Patient Sequence Number: 1
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