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
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): B BRAUN MEDICAL INC.; bethlehem PA 18018
• MDR Report Key: 16627701
• Report Number: MW5116009
• Device Sequence Number: 7149936
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345(11)200511(10)257190(92)98224842
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIALOG PLUS
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown