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	Cardiac Arrest (1762)
Date of Event	05/22/2026
Type of Reportable Event	Death
Event or Problem Description
Per customer description: on (b)(6) 2026, reported on 5/26/2026.Patient coded approximately 3 hours into therapy.Patient was transferred to icu and passed the following day.The patient coded approximately three hours into treatment.Cpr was initiated, saline was administered, and all blood was successfully returned.It was reported that a patient coded during therapy, requiring cardiopulmonary resuscitation (cpr) and emergency intervention.Cpr was initiated immediately, and the patient was subsequently transferred to the intensive care unit (icu), where the patient later passed away.Following the event, the device was disinfected and subsequently returned to operation under monitoring.The provided machine data records cover the period from 20260524 to 20260609, during which the device was in use and no abnormalities were reported.No machine data from the date of the event (20260522) was available, as the system stores a maximum of 20 records and older data is automatically overwritten.Therefore, the next available treatment record following the reported event was analysed in detail.The record from 20260524 shows a complete and unremarkable cycle of preparation, therapy, end of therapy, and disinfection, with no indication of any device malfunction.All safety-relevant functions of the device are verified through self-tests prior to therapy initiation; therapy cannot be started unless these tests are successfully completed.During therapy, all components and safety-relevant functions are continuously monitored in accordance with applicable requirements.The device is equipped with an alarm system designed to detect and signal malfunctions.Based on the available information, there is no indication of any product deviation.Furthermore, there is no evidence that the device contributed to the patient's death, and no causal relationship between the device and the event is suspected.In summary, based on the investigation results, the case is assessed as not reportable to the national competent authority.

• 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: 25619549
• Report Number: 2521402-2026-00625
• Device Sequence Number: 9102273
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345(11)250407(10)040725CAD
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 06/25/2026
• Report Date (Section F): 06/26/2026

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: 040725CAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/26/2026
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2026
• 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
• Date Report Sent to FDA: 06/26/2026