MAUDE Adverse Event Report: B BRAUN MEDICAL INC. DIALOG PLUS HEMODIALYSIS MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number DIALOG PLUS

Device Problems Material Disintegration (1177); Particulates (1451)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2023

Event Type  malfunction  

Event Description

Manufacture: b braun dialog plus dialysis machine.The fpe flow pump gear head had a magnet in the drive assembly that disintegrated leaving black particulate matter in the internal hydraulic tubing and filters.The disintegrated ferrite can lead to future problems with regulators, solenoid valves and pumps.The machine serial number is (b)(4).The manufactures gear pump part number is 34561927.A product complaint was filed with the manufacture b braun on 3/23/23.

• Brand Name: DIALOG PLUS HEMODIALYSIS MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): B BRAUN MEDICAL INC.; bethlehem PA 18018
• MDR Report Key: 16627701
• MDR Text Key: 312217104
• Report Number: MW5116009
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345(11)200511(10)257190(92)98224842
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALOG PLUS
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1