MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER 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 Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Chest Tightness/Pressure (2463)

Event Date 03/08/2019

Event Type  Injury  

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.

Event Description

It was reported that 35 minutes after starting treatment with a polyflux 140h dialyzer, the patient experienced difficulty breathing, chest tightness and the blood pressure (bp) had increased to 176/103mmhg. Treatment was stopped and the extracorporeal blood was returned to the patient. The patient received dexamethasone 5mg and iv 20ml 50% glucose (blood glucose was measured to be 6. 2mmol/l). Forty-five minutes later bp was 138/91 mmhg. The dialyzer was changed to a fb150 dialyzer. It was reported two hours and ten minutes after the events began the patient¿s symptoms were improved, bp155/12mmhg. Two hours and twenty-five minutes later treatment was completed and bp was bp155/96mmhg. No additional information is available.

• Brand Name: POLYFLUX 140H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• 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: 8540934
• MDR Text Key: 142794571
• Report Number: 9611369-2019-00054
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K043342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 112465
• Device Lot Number: 8-5815-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 04/23/2019 Patient Sequence Number: 1