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

Model Number	710200S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/16/2021
Type of Reportable Event	Death
Event or Problem Description
As reported by user facility: the venous line detached from the catheter two (2) hours into treatment causing significant blood loss of 500+ ml.The venous pressure reading of the dialysis machine was around 200 mmhg during treatment and then dropped rapidly to 40 mmhg when the venous line detached.Since the lower alarm limit of the dialog+ machine was set to 20 mmhg, it did not trigger an alarm.The nurse responded within one (1) minute of the pressure drop to find that the venous line had become disconnected.The site was not covered.It was in plain sight.The patient received cpr and was transported to the hospital.The patient did pass away several days later.Please note that this is the same patient and incident as reported in mdr # 2521402-2021-00024.Additional importer narrative: the dialog+ dialysis machine was technically inspected by the customer's technician after the described event.It was confirmed that it operated as intended and has been cleared for use by the customer.Dependent on the pressure drop and the alarm limits set, the pressure monitoring system of a dialysis machine does not reliably detect a disconnection or dislodgement of the venous patient access.Therefore, the instructions for use of the dialog+ dialysis machine shows the following warning: risk to patient due to blood loss if cannulas get disconnected or dislodged! standard monitoring function of the dialysis machine cannot ensure detection if the cannulas get disconnected or dislodged.Ensure that the access to the patient always remains fully visible during therapy.Ensure that cannulas are adequately fixed.Regularly check patient access.Venous lower limit should be set to greater than or equal to 20 mmhg in tsm (technical service mode).

• Brand Name: DIALOG+
• Common Device Name: DIALYZER, HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• MDR Report Key: 11968048
• Report Number: 2521402-2021-00025
• Device Sequence Number: 4268730
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/09/2021
• Report Date (Section F): 06/09/2021

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 Model Number: 710200S
• Device Catalogue Number: 710200S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/24/2021
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2021
• 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; Hospitalization
• Date Report Sent to FDA: 06/09/2021