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

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.

• Brand Name: POLYFLUX 140H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 7893849
• MDR Text Key: 120862685
• Report Number: 9611369-2018-00109
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K043342
• Number of Events Reported: 1
• 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 Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 103530
• Device Lot Number: 8-5709-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/11/2018
• 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.