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); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that 5 (five) patients experienced hypotension, dyspnea, swelling (face and lips) and itch during treatment with polyflux 140h. The symptoms ranged from mild to severe. Some of the patients experienced symptoms immediately upon connection and some after 30 minutes into treatment. The patients with mild symptoms were treated with adrenaline injection, corticoid and antihistamine (drug names not specified) and therapy was discontinued for those patients with severe reactions. At the time of this report the patients were reported to be in stable condition. 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: 8160462
• MDR Text Key: 130219651
• Report Number: 9611369-2018-00140
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 112465
• Device Lot Number: 7-5815-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/10/2019
• 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: 12/13/2018 Patient Sequence Number: 1