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

Catalog Number 112465

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Cough (4457)

Event Date 08/29/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the patient experienced a reaction to a polyflux 140h set.Approximately twenty minutes into hemodialysis therapy, the patient complained of chest tightness, a cough, and difficulty breathing.After two minutes the patient¿s symptoms were not better, so treatment was paused and the patient was treated with 5mg intravenous dexamethasone, 50% glucose(20ml), calcium gluconate(10ml), 3ml/min of inhalation oxygen, and 250ml of saline solution.After forty minutes the symptoms subsided, and therapy resumed.No further information was available at the time of this report.

Manufacturer Narrative

Additional information has been added to h6 and h10: 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: 17887950
• MDR Text Key: 325128604
• Report Number: 9611369-2023-00193
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414102753
• UDI-Public: (01)07332414102753
• 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,Followup
• Report Date: 11/06/2023

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: 112465
• Device Lot Number: 2-5830-H-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/06/2023
• 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
• Treatment: 0.09% NACL SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male