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	02/04/2026
Type of Reportable Event	Death
Event or Problem Description
According to the complainant, on (b)(6) 2026, at approximately 11:30 am, a patient experienced a cardiac arrest while undergoing hemodialysis treatment.The customer reported that the patient "coded" during dialysis therapy.The event occurred during active treatment on the dialysis machine.The patient was resuscitated and transferred to the intensive care unit (icu).Subsequent follow-up with the account revealed that on (b)(6) 2026, the family withdrew care and the patient died.It was reported that during therapy the patient had a cardiac arrest.The patient was resuscitated and transferred to the icu.The next day the patient's family withdrew care and the patient died.Analysis: the service report received shows that the machine was checked by a b.Braun technician, and no failure was found.The machine worked as intended.The investigation of the received machine data record shows that during preparation all self-tests were passed, and therapy was started.Within the first 2 hours the therapy ran smoothly without any conspicuous alarms.At approximately 2:08 hours after patient connection, the machine began triggering a series of blood-side pressure alarms.Over the next 10 minutes, the following alarms occurred: "arterial pressure - lower limit" (14 times)."arterial pressure - lower limit (sup)" (once)."venous pressure - lower limit - check access" (10 times)."venous pressure lower limit (sup)" (6 times).Each alarm was acknowledged by the user.Every series of alarms started with "arterial pressure - lower limit" which was caused by a decrease in arterial pressure.Generally, such a decrease can have multiple causes, and the exact cause cannot be determined from the machine data record; however, it is plausible that, in this situation, the decrease in arterial pressure was related to the patient experiencing the cardiac arrest described.Importantly, a decrease in arterial pressure does not indicate a malfunction of the machine.Because the blood pump stopped because of the alarm "arterial pressure - lower limit", follow-up alarms like "venous pressure - lower limit - check access" and/or "venous pressure lower limit (sup)" were triggered.At approximately 2:19 hours after patient connection, all alarms were acknowledged and the blood pump was restarted.About 9 minutes later, the user transitioned from therapy to the end-of-therapy phase, and the patient was reinfused.The verification of other parameters and sensor values from the trend data did not show any indication of an abnormality or a malfunction of the machine.Summary: the service report confirms that the machine was inspected by a b.Braun technician, who found no malfunction.Additionally, the analysis of the machine data record demonstrates that the device operated as intended, with no product deviation detected.The analysis of all available data confirms normal machine functionality.There is no product deviation.There is no indication that the machine contributed to the cardiac arrest and there is no suspected association between the death and the use of the product.Thus, 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: 24485182
• Report Number: 2521402-2026-00265
• Device Sequence Number: 16123643
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345(11)121203(10)120312DAV
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/02/2026
• Report Date (Section F): 02/04/2026

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: 120312DAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/04/2026
• Device Age: 13 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• 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