MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG+; HIGH PERMEABILITY

Model Number	710200S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Insufficient Information (4580)
Date of Event	08/19/2020
Type of Reportable Event	Death
Event or Problem Description
As reported by user facility: bio-med reported a patient coded and passed away during a treatment.Bio-med verified all the machine safety calibrations and at the time of the incident the dialog machine was operating within specified limits and tolerances.
Event or Problem Description
This report has been identified as b.Braun medical inc.Internal report#: (b)(4).This follow-up report is being filed for corrections.Section b2 has been changed.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: DIALOG+
• Common Device Name: HIGH PERMEABILITY
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• MDR Report Key: 10454476
• Report Number: 2521402-2020-00005
• Device Sequence Number: 2816421
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• Combination Product (Y/N): N
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020
• Report Date (Section F): 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 710200S
• Device Catalogue Number: 710200S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/19/2020
• Device Age: 16 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/03/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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; Other
• Date Report Sent to FDA: 11/03/2020