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	07/22/2025
Type of Reportable Event	Death
Event or Problem Description
As reported by the user facility: an 84-year-old male patient with a significant medical history was undergoing hemodialysis therapy using an optiflux f180nr dialyzer.During the session, approximately 2.44 hours into therapy, the patient became unresponsive.The dialysis nurse noted hypotension during treatment and subsequently observed the patient to be unresponsive, with blood pressure and pulse oximetry readings unobtainable.Blood was returned to the patient, and the attending physician assessed the patient.Given the patient's do not resuscitate (dnr) status, no medical intervention was performed.The patient was pronounced deceased at (b)(6) 2025.Note from the manufacturer: a technical safety inspection of the machine was performed.The tsi was passed, confirming that the machine works as intended.The investigation of the received machine data record from (b)(6) 2025, 8:18 o´clock shows that during preparation all self-tests were passed, and therapy was started.Approx.21 minutes after therapy start the machine started to trigger the alarm "tmp out of alarm limits" because the transmembrane pressure tmp exceeded the limit.This alarm has no further machine reaction and is only to inform the user.This alarm was triggered further 35 times until approx.56 minutes after therapy start.The machine data record shows that the transmembrane pressure tmp was in the range of -15 to -10 mmhg at therapy start, increased to -5 to 5 mmhg when the alarms started, and increased up to 20 mmhg during therapy.The tmp values from the machine data record do not indicate a malfunction of the machine.An automatic blood pressure measurement abpm was performed at approx.49 minutes after therapy start with the result 78/48 mmhg, pulse rate 80 bpm.As the systolic pressure was too low, the machine triggered the alarm "abpm: sys press.Is too low".At approx.1:02 hours after therapy start a further abpm measurement was performed with the result 79/50 mmhg, pulse rate 65 bpm.As the systolic pressure was still too low, the machine triggered the alarm "abpm: sys press.Is too low".1 minutes later a further abpm measurement was performed with the result 78/46 mmhg, pulse rate 86 bpm.As the systolic pressure was still too low, the machine triggered the alarm "abpm: sys press.Is too low".At approx.2:03 hours after therapy the machine triggered the alarm "venous pressure - upper limit" because the venous pressure upper limit was exceeded and switched into a patient safe mode (with blood pump stop).Due to the stopped blood pump the machine triggered the follow-up alarms "venous pressure - lower limit - check access" and "venous pressure lower limit (sup)".2 seconds later, these alarms were acknowledged by the user.At approx.2:19 hours after therapy start a further abpm measurement was performed unsuccessfully.Therefore, the machine triggered the alarm "abpm: pulse signal very low".3 minutes later a further abpm measurement was performed unsuccessfully again.Therefore, the machine triggered the alarm "abpm: pulse signal very low".Shortly after this, the venous pressure pv increased to 280 mmhg and exceeded the upper limit.Therefore, the machine triggered the alarm "venous pressure - upper limit".This increase does not indicate a malfunction of the machine.2 seconds later, this alarm was acknowledged by the user.19 seconds later, the machine triggered the alarm "venous pressure - lower limit - check access" again and this alarm was acknowledged 2 seconds later.2 minutes later, the machine triggered the alarm "venous pressure - upper limit" again and 3 seconds later acknowledged by the user.At approx.2:27 hours after therapy start a further abpm measurement was performed unsuccessfully.Therefore, the machine triggered the alarm "abpm: pulse signal very low".24 seconds later, the machine triggered the alarm "venous pressure - upper limit" again.2 seconds later, the alarm was acknowledged by the user.But the alarm was triggered again a few seconds later.2 seconds later the alarm was acknowledged by the user.Approx.1 minute later, the machine triggered the alarm "arterial pressure - upper limit" because the arterial pressure exceeded the upper limit.This alarm was also acknowledged 2 seconds later.At approx.2:32 hours after therapy start, no more "red" was detected at the red detector rdv of the safety air detector sad, i.E.The venous line was filled with transparent fluid.It is plausible that the patient was reinfused with saline from a bag which would also explain the increase of the arterial pressure pa.Shortly after this, the machine triggered the alarm "arterial pressure - lower limit".Due to the stopped blood pump the machine triggered the follow-up alarms "venous pressure - lower limit - check access" and "venous pressure lower limit (sup)".These alarms were acknowledged by the user.But the machine triggered the alarm "arterial pressure monitoring error (sup)" because the machine did not detect enough arterial pressure pulsation.The arterial pressure value remained at -250 since the last 2 minutes.The blood pump remained stopped for the rest of this machine data record.A further abpm measurement was performed unsuccessfully, and the machine triggered the alarm "abpm: pulse signal very low".At approx.2:39 hours after therapy start, the user changed from therapy to end of therapy phase.The analysis of the machine data record and all relevant parameters documented therein revealed no anomalies or indications of a malfunction of the device.There is no product deviation.In conclusion, based on the analysis and evaluation of the reported and provided information there was not malfunction of the device and the device has not led 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: 22850971
• Report Number: 2521402-2025-00299
• Device Sequence Number: 18243657
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345(11)240724(10)071924CAD
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/20/2025
• Report Date (Section F): 08/18/2025

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: 071924CAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/23/2025
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• 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 Age: 84 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Date Report Sent to FDA: 08/18/2025