MAUDE Adverse Event Report: B. BRAUN AVITUM 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	Insufficient Information (4580)
Date of Event	01/30/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).We were informed that a patient died during dialysis therapy.The patient was on a ventilator in icu.Investigation upon further enquiry, the customer did not provide any further information.A cause of death was not disclosed.No machine data records were made available for investigation.The dialog+ dialysis machine was inspected by a customer's technician.The inspection did not show a malfunction, the machine operated as intended.There was no product deviation.All safety-relevant functions are tested during the machine's self-tests in preparation.A therapy cannot be started without passing the self-tests.If a safety-relevant defect occurs during therapy the machine triggers an alarm and switches to patient-safe mode.Since there was no product deviation, no further action will be taken.If additional pertinent information becomes available a follow-up report will be filed.
Event or Problem Description
As reported by the user facility: customer states that he was told by his facility's safety officer that the dialysis nurse left the patient room to use the restroom, and that when she returned the patient's ventilator was alarming so she called for help from the icu staff.Patient had been made a dnr earlier in the day so no acls was performed at this time, and patient expired.Patient was then removed from the dialysis machine.

• Brand Name: DIALOG+®
• Common Device Name: KDI-DIALYZER, 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4047197287
• MDR Report Key: 16406010
• Report Number: 3002879653-2023-00003
• Device Sequence Number: 5898948
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/20/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown