MAUDE Adverse Event Report: B. BRAUN AVITUM AG DIALOG+®; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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	11/04/2024
Type of Reportable Event	Death
Event or Problem Description
As reported by the user facility: on 11/12/2024, b braun us device manufacturing, llc, was notified of an incident occurring on (b)(6) 2024 involving dialog machine serial number (b)(6).The incident was a patient passed away while receiving treatment on the machine.The customer reported that the patient's blood pressure dropped; iv fluids were given but no attempts were made to resuscitate because the patient had a dnr directive.At this time, the customer stated that they do not think the machine was related to the incident.The machine is scheduled to undergo a technical safety inspection, at customer's request.The machine's hours of operation are unknown at this time but will be provided in the tsi report.The work order is (b)(4).Additional manufacturer narrative: it was reported that during a therapy with the dialog dialysis machine reported in this case, the patient passed away.Cause of death was a cardiac arrest.The customer stated that no relation to the device is established.The service report received from the technical safety inspection (tsi) shows no failure of the machine.All tests were passed.The investigation of the received machine data record of the concerned therapy shows that the machine had passed all self-tests in preparation.Therefore, therapy start was possible.According to the machine's data record, approx.49 minutes after therapy start, the user changed the ultrafiltration (uf) volume from 3300 ml to 2800 ml.4 minutes later, the user activated minimum uf.Minimum uf remained active for the rest of therapy.Approx.58 minutes after therapy start, the user gave an arterial bolus of 200 ml (infusion of a fluid bolus using the arterial blood pump).The venous pressure (pv) was at approx.130 mmhg when the blood pump was last started after the arterial bolus was finished.At 1:21 hours after therapy start, the pv exceeded the upper limit (set to 188 mmhg) and consequently the machine triggered the alarm "venous pressure - upper limit", followed by the machine's default to patient-safe mode.Shortly after this, the machine triggered the alarm "venous pressure - lower limit - check access".In this case, this alarm was triggered as a follow-up alarm as pv had decreased due to the stopped blood pump caused by the previous alarm.The user acknowledged both alarms and the blood pump restarted.1,5 minutes later, the red detector (rdv) of the safety air detector (sad) showed no "red" anymore, however, 30 seconds later it detected "red" again.This behavior occurred once again 1 minute later.Then the arterial pressure (pa) exceeded the upper limit and the machine triggered the alarm "arterial pressure - upper limit" and switched to patient-safe mode.The data record shows that the pa had increased from approx.-155 mmhg up to 38 mmhg.The scenario described above can be explained by fluid administration to the patient without using the "arterial bolus" function, explaining the sequences of no "red" being detected at rdv.Compression of a saline bag (used for fluid administration) by the operator is a plausible explanation for such an increase in pa as seen in the data record.However, this scenario cannot be determined by machine data record analysis.The arterial pressure alarm was acknowledged, and the blood pump restarted.20 seconds later the machine triggered the alarm "venous pressure upper limit (sup)", which was acknowledged by the operator so that therapy was further performed.18 seconds later, the rdv no longer recognised 'red' for the rest of this machine data record 1,5 minutes later, the blood pump was stopped by the user and 40 seconds later started again.Again 1,5 minutes later, the blood pump was stopped by the user and remained stopped for the rest of this machine data record.Shortly after this, the pv and the pa showed 0 mmhg.Therefore, the machine triggered the alarm "venous pressure lower limit (sup)".The fact that the pressure values pv and pa fell to 0 can be plausibly explained by the fact that the lines of the pressure transducers were removed from the machine.Approximately 1:42 hours after therapy start, the user switched the device from "therapy" to "end of therapy" phase.The verification of other parameters and sensor values from the data record, e.G., the blood leak detector (bld), the balance chamber membrane movement, the transmembrane pressure (tmp), blood side pressure sensors, dialysis fluid side temperatures and sad did not reveal any abnormality or indication of a malfunction of the device.Thus, summarizing what is written above, the evaluation of the machine's data record of the affected therapy confirms that the machine worked as intended and specified without any deviation.This is further supported by the tsi report which confirmed that there was no failure of the device.In general, all safety relevant functions are tested during the self-tests in preparation.Without having passed the self-tests a therapy start is not possible.If during therapy a safety relevant malfunction occurs, the machine triggers an alarm and switches to patient-safe mode.All pressure sensors are tested in preparation.If the pressure values are not in the correct range, the machine triggers an alarm, and a therapy start is not possible.During therapy, pressure values are continuously monitored and if the values are not in the correct range, the machine triggers an alarm and switches to patient-safe mode.In conclusion, the machine worked as intended and specified and there was no malfunction.Investigation of the machine's data record and the technical safety inspection confirmed, that the device has not led to the patient's death.This is in line with the customer's statement.This case is classified as not reportable to the competent authority by the manufacturer.

• Brand Name: DIALOG+®
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• MDR Report Key: 20907070
• Report Number: 2521402-2024-00129
• Device Sequence Number: 9133539
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345(11)160803(10)080316CAD
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2024
• Report Date (Section F): 11/12/2024

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: 080316CAD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/14/2024
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 66 KG