MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 210H; 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 Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Tachycardia (2095); Bronchospasm (2598)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that 20 minutes after starting treatment with a polyflux h dialyzer, the patient experienced respiratory insufficiency, bronchospasm and sinus tachycardia (> 120 bpm), further described as a hypersensitivity reaction.The patient was administered oxygen therapy, bronchodilators and hydrocortisone.Treatment was discontinued, and the extracorporeal blood was returned to the patient.The patient was recovered from the event.It was reported treatment was completed after switching to a non-baxter dialyzer.No additional information is available.

Manufacturer Narrative

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 210H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9404511
• MDR Text Key: 185193006
• Report Number: 9611369-2019-00182
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 115821
• Device Lot Number: 9-9052-H-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CELLULOSE TRIACETATE DIALYZER
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 88