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

Model 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	12/02/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation of the received trend shows that during preparation the self test were performed and passed successfully.The patient was connected to the device and therapy was started at 12:02 o´clock.The therapy was planned to remove 3500 ml ultrafiltration volume in 3 hours therapy time.At 13:18 o´clock, the machine triggered the alarm "venous pressure - upper limit", because the venous pressure pv increased since therapy start.The increase of pv during therapy is caused by ultrafiltration and does not indicate a malfunction.This alarm was acknowledged by the user and therapy was continued.At 13:39 o´clock the machine triggered the alarm "arterial pressure - lower limit", because the arterial pressure pa decreased since therapy start.Decrease of pa during therapy is caused by ultrafiltration and does not indicate a malfunction.This alarm was also acknowledged by the user and therapy was continued.At 14:30 o´clock the user changed the uf volume to 3200 ml.This caused a decrease of the transmembrane pressure tmp.3 minutes later the machine triggered a tmp alarm, because the tmp was out of the alarm limits.It is plausible that the decrease of tmp was caused by the change of the uf volume.Another 3 minutes later the machine triggered the alarm "arterial pressure - lower limit", because the pa underran the lower limit value.As an accelerated decrease of pv can be seen in the trend since 14:33 o´clock, this can be an indication for a reduced amount of available blood from the patient due to a hypotension.During the next minutes, more blood-side pressure alarms were triggered.It is plausible that they were caused by the emergency situation described by the complainant.None of these alarms indicates a malfunction of the device, and the machine reaction was as intended (patient safe mode).At 14:40 o´clock therapy was aborted.Achieved therapy time 2:37 hours, achieved uf volume 2970 ml.The patient was reinfused.The investigation of the received service report shows that a technical safety inspection was performed and that the machine had no failure.As the service report and the trend shows no failure of the machine, there is no product deviation.Risk assessment: there is no product deviation.All safety relevant functions were tested during the self-tests in preparation.Without passed selftests a therapy start is not possible.If during therapy the machine had a safety relevant defect the machine triggers an alarm and switches into a patient safe mode.There is no risk for patients, users or third parties, which was not already assessed and minimized by implementing of risk minimizing measures.Measures: since the continuous trend evaluation of the complaints did not show an increase in frequency of occurrence of the situation complained about and there is no product deviation, no further actions will be taken.
Event or Problem Description
As reported by the user facility: patient passed away 2 hrs after treatment.Patient was removed from therapy with 20 minutes left.

• Brand Name: DIALOG+®
• Common Device Name: KDI-DIALYZER, HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• MDR Report Key: 16089578
• Report Number: 2521402-2023-00001
• Device Sequence Number: 13961563
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/03/2023

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: 710200L
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/08/2022
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2023
• 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