MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 170H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 103579

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Palpitations (2467)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that after 10 minutes of starting treatment with a polyflux 170h dialyzer, the patient experienced shortness of breath, palpitations and nausea.Treatment was discontinued.It was reported the patient¿s ¿symptoms settled after 10-15 minutes¿.There was no report of any medical intervention associated with this event.It was reported this was a first time use with the polyflux 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.

• Brand Name: POLYFLUX 170H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10257682
• MDR Text Key: 199894121
• Report Number: 9611369-2020-00084
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 103579
• Device Lot Number: 0-4716-H-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1