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

Catalog Number 112466

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

Patient Problems Chest Pain (1776); Hypersensitivity/Allergic reaction (1907); Discomfort (2330); Diaphoresis (2452)

Event Date 06/18/2023

Event Type  Injury  

Event Description

It was reported that approximately 24 minutes after starting treatment with a polyflux 170h, the patient experienced chest tightness, discomfort, and profuse sweating.Vital signs were taken showing a temperature of 36.5°c, pulse: 62 beats/min, respirations: 17 beats/min, and blood pressure: 108/56mmhg.Dialysis treatment was stopped.The patient was administered nasal catheter oxygen inhalation and intravenous injection of dexamethasone (5mg).Approximately six minutes later, the patient reported the symptoms were "slightly relieved".The dialyzer and tubing were replaced and treatment was started, further specified as ¿the process went smoothly¿.No additional information is available.

Manufacturer Narrative

E1: initial reporter address - (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.

• 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: 17392956
• MDR Text Key: 319742960
• Report Number: 9611369-2023-00129
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414102760
• UDI-Public: (01)07332414102760
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2023

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 Catalogue Number: 112466
• Device Lot Number: 1-4935-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/25/2023
• 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
• Patient Age: 46 YR
• Patient Sex: Male