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

Model Number	710200U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2015012.B.Braun medical inc (importer) is submitting this report on behalf of b.Braun avitum ag (manufacturer).This report has been identified as b.Braun avitum internal report # (b)(4).Initial information was received from the facility biomed.The machine trend file and additional information has been requested from the facility and the investigation is on-going 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: 5 minutes into the start of treatment a patient has a cardiac arrest.The patient status has not been given by the user facility.The bio med technician stated when the treatment ended he was asked to take dialysate samples to send to the lab.When he got to the machine it was in bypass and did not know for how long.He then tested the function of the blood leak detector for proper operation and it was working within specifications.The bio med technician indicated they would run a mock treatment to obtain samples before and after the event.
Additional Manufacturer Narrative
Exemption number e2015012.(b)(4).No further information or trend data records were provided for the dialog+ machine.The information that was provided and the inspection of the dialog+ machine by the biomed technician does not give any evidence of a product failure.End stage renal disease (esrd) as cause for cardiac disease is described frequently in the medical literature and cardiovascular disease leading to cardiac arrest is the most common cause of death in dialysis and esrd patients.Severe cardiac events, including cardiac arrest, do occur during dialysis therapy and are related to the underlying disease.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: DIALOG+®
• Common Device Name: HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM, AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, germany D-342 12; GM D-34212
• MDR Report Key: 6864693
• Report Number: 3002879653-2017-00013
• Device Sequence Number: 10787872
• Product Code: KDI
• UDI-Device Identifier: 04046964285615
• UDI-Public: (01)04046964285615
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K083460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2017
• Report Date (Section F): 01/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 710200U
• Device Catalogue Number: 710200U
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/12/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/16/2018
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 01/16/2018
• 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: Other
• Date Report Sent to FDA: 01/16/2018