MAUDE Adverse Event Report: B. BRAUN AVITUM AG DIALOG®; HIGH PERMEABILIT

Model Number	710200L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Dyspnea (1816)
Date of Event	06/22/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report has been identified as b.Braun medical, inc.Internal report number 400560170.The technical inspection of the dialog+ machine did not show any malfunction.It operated as intended.The evaluation of the data record of the dialog+ machine showed a successfully passed preparation phase.In the first 37 minutes of the therapy numerous arterial pressure alarms (arterial pressure - lower limit or arterial pressure - lower limit (sup)) were triggered often followed by venous pressure alarms (venous pressure lower limit (sup) due to the blood pump stop because of the alarm.Following these alarms, the dialog+ machine switched into patient-safe mode (blood pump stop, venous tube clamp sakv closed).From the trend data, the cause for these alarms is not comprehensible.The alarms were all acknowledged in a timely manner by the operator.About 37 minutes into therapy an air alarm was triggered (sad-air! and s.A.D.(sup)).Following this alarm, the dialog+ machine switched into patient-safe mode.The alarm was acknowledged by the user and the therapy was continued.Six minutes later, the alarm abpm: sys press.Is too low was triggered because the blood pressure measured by the respective module of the dialog+ machine was 97/64 mmhg, pulse rate 94 bpm and thus below the set limit.Ten seconds later minimal uf was activated by the operator and shortly thereafter, no more red was detected at the red detector of the sad, indicating that the blood in the extracorporeal circuit had been returned to the patient.This was obviously the time when the therapy was stopped because the patient had developed the described symptoms and was disconnected from the dialysis machine.The evaluation of the trend data show no indication of a malfunction.The technical inspection of the dialog+ on-site as well as the evaluation of the data record show that the dialysis machine operated as intended.
Event or Problem Description
As reported by the user facility: it was reported that a patient coded during a treatment with a dialog+ dialysis machine and passed away.As per facility policy the customer requested an evaluation of the dialysis machine by the manufacturer.The customer described the incident in more detail as follows.About 46 minutes into therapy, the patient developed shortness of breath.Oxygen (2l/nc) and saline was administered and the dialysis treatment was discontinued.Since the symptoms did not resolve, oxygen was increased from 2 to 10l via mask and the rapid response team was called.The patient became unresponsive and continued to deteriorate.The md who was called pronounced the patient head.The patient had a dnr order.The customer stated that there was no indication of a malfunction of the dialog+ machine.

• Brand Name: DIALOG®
• Common Device Name: HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15078106
• Report Number: 3002879653-2022-00020
• Device Sequence Number: 4822179
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 710200L
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown