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

Model Number	710200S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).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 the user facility: customer reported patient coded on the machine and was questioning the results of the electrolyte composition of the dialysate that was tested.

• 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
• MDR Report Key: 16364616
• Report Number: 2521402-2023-00006
• Device Sequence Number: 15268554
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2023
• Report Date (Section F): 02/06/2023

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: 710200S
• Device Catalogue Number: 710200S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2023
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2023
• 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: Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/06/2023