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
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).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).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
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 Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).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).If the venous needle slips out or the connection of the vascular access detaches during treatment, the patient's blood is no longer returned to the patient.Instead, it is pumped to the environment, while blood is still being taken from the patient through the arterial needle.Depending on the blood flow rate, this can lead to a life-threatening situation within a short time.As outlined above, it is state of technology that a needle dislodgement will not be detectrf in any case by a dialysis machine, dependent on the pressure drop caused by the needle dislodgment.Based on the available information, there is no evidence for a defect or a malfunction of the device.If additional pertinent information becomes available a follow-up report will be filed.

• 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: 11968052
• Report Number: 3002879653-2021-00025
• Device Sequence Number: 17254211
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K083460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/15/2021
• 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