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

Catalog Number	710200S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/25/2025
Type of Reportable Event	Death
Event or Problem Description
As reported by the user facility:according to the complainant, the patient coded and passed away while undergoing dialysis treatment.The treatment duration was reported to be less than two hours.Although requested, no additional information has been made available.It was reported that a patient coded and passed away while undergoing dialysis treatment.The treatment duration was reported to be less than two hours.Unfortunately, no additional information was provided.Despite multiple follow-up attempts, no details regarding a technical inspection or the machine's condition were shared.Furthermore, no machine data records were made available to support the investigation.As a result, the assessment was conducted based solely on the information and data at hand.All safety relevant functions are tested during the machine's self-tests in preparation.If there is a safety relevant error, no therapy start is possible.If a safety relevant malfunction occurs in therapy, the machine triggers an alarm and switches to patient-safe mode.Based on the available information, the cause for the patient death is not comprehensible.No machine failure was reported.Based on the preceding information, we do not observe any evidence suggesting a link between the death and the machine.The event is considered as not reportable 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: 23359067
• Report Number: 2521402-2025-01141
• Device Sequence Number: 8861078
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608(11)230530(10)053023
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 10/22/2025
• Report Date (Section F): 10/22/2025

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: 710200S
• Device Lot Number: 053023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/25/2025
• Device Age: 28 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• 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
• Date Report Sent to FDA: 10/22/2025