MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 140H; 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 Abdominal Pain (1685); Hot Flashes/Flushes (2153)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

It was reported that a patient experienced sweating and abdominal pain while being treated with hemodiafiltration using an polyflux 140h apac dialyzer.During the treatment the patient presented with sweating and abdominal pain likely associated with intradialytic hypotension (idh).The fluid removal was stopped and 50%g-s20ml was static-injected.The patient was under ecg monitoring and the patient's ¿signs¿ were closely monitored.However, symptoms were not alleviated, and the patient was given a static push of 10% calcium glucose 10ml +0.9%ns 40ml, and the hdf treatment was stopped.No additional information is available.

Manufacturer Narrative

H10: based on additional information received, the polyflux 140h was determined not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: POLYFLUX 140H
• 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 ; 2242702068
• MDR Report Key: 13164637
• MDR Text Key: 288515927
• Report Number: 9611369-2021-00380
• 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: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 112465
• Device Lot Number: 0-5823-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2022
• 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