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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 140H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 140H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 103530
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Conjunctivitis (1784); Dyspnea (1816); Edema (1820)
Event Date 08/13/2018
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 a patient experienced facial edema, conjunctivitis and dyspnea while performing therapy for the first time using a polyflux 140h. The incident occurred five minutes into treatment. Treatment was immediately terminated and the patient was treated with 200 mg of prednisolone, 1 amp of tavergil ("volume intravenous"). The patient was hospitalized in the intensive care unit. At the time of this report, the patient outcome was reported as "stable". No additional information is available.
 
Manufacturer Narrative
The actual device was received for evaluation. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NamePOLYFLUX 140H
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
hechingen
MDR Report Key7893849
MDR Text Key120862685
Report Number9611369-2018-00109
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K043342
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number103530
Device Lot Number8-5709-H-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/20/2018 Patient Sequence Number: 1
Treatment
BICARBONATE; FX-CORDIAX.; BICARBONATE; FX-CORDIAX.
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