MAUDE Adverse Event Report: B. BRAUN AVITUM AG DIALOG+®; KDI-DIALYZER, HIGH PERMEABILIT

Catalog Number	710200L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Electric Shock (2554)
Type of Reportable Event	Death
Event or Problem Description
As reported by the user facility: patient coded, all other information is unknown at this time.A patient death was reported while using the machine.Despite several attempts, no sample, no machine data record of the affected therapy, or additional information was made available.A technical safety inspection (tsi) of the machine was performed and passed successfully, confirming that the machine worked as intended, with no failures detected and no product deviation identified.All safety-relevant functions are verified during mandatory self-tests of the machine in its preparation phase.Therapy cannot start unless these self-tests are successfully completed.During therapy, all safety-relevant components and functions are continuously monitored.If a safety-relevant malfunction occurs, the machine triggers an alarm and switches to patient-safe mode.Conclusion: based on the analysis and evaluation of the reported information and the outcome of the technical safety inspection, there was no malfunction of the device, and the device did not contribute to the patient's death.This case is classified as not reportable to the competent authority by the manufacturer.

• Brand Name: DIALOG+®
• Common Device Name: KDI-DIALYZER, HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• MDR Report Key: 24187824
• Report Number: 2521402-2026-00013
• Device Sequence Number: 18158805
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345(11)160803(10)080316CAD
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2026
• Report Date (Section F): 12/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 710200L
• Device Lot Number: 080316CAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/29/2025
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown