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

Catalog Number 115821

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

Patient Problems Erythema (1840); Low Blood Pressure/ Hypotension (1914); Rash (2033)

Event Date 07/06/2021

Event Type  Injury  

Event Description

It was reported that after 15 minutes of dialysis treatment with a polyflux 210 h, the patient experienced rash, erythema all over the body, and hypotension.Elevation of ige and tryptase were reported.Treatment was stopped and the patient was treated with corticosteroids and antihistamine.The patient's blood pressure recovered and the dialyzer was replaced.The patient was transferred to a cellulose triacetate dialyzer without further reactions to the 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
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• 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 Key: 15869473
• MDR Text Key: 304355058
• Report Number: 9611369-2022-00232
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414120894
• UDI-Public: (01)07332414120894
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 115821
• Device Lot Number: 1-9014-H-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention