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

Model Number	710200S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been identified s b.Braun medical inc.Internal report number 400489405.The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: it was reported that a patient went unresponsive at the end of a therapy with a dialog+ dialysis machine.The patient came by wheelchair.The staff remarked how he normally walked in the clinic.The patient said that he had not felt very good after starting a new shingles medication.Toward the end of the treatment the patient went unresponsive, staff began cpr and the patient was transported to the emergency room by ambulance.
Additional Manufacturer Narrative
This report has been identified s b.Braun medical inc.Internal report number (b)(4).Upon further inquiry, it was reported that the patient became unresponsive approximately 3 hours 30 minutes into therapy.The treatment was almost complete.The patient did not have any complaints before becoming unresponsive.There was no indication of a malfunction of the dialog+ machine.The customer does not believe that the dialysis machine had anything to do with the patient issue.Further details were not disclosed by the customer.The dialog+ machine was technically inspected by the customer's technician.It operated as intended.There was no malfunction.The dialog+ machine was put back into service and is currently in use without any issues.The data record of the dialog+ machine was not captured and was therefore not available for investigation.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: DIALOG+
• Common Device Name: DIALYZER, HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• MDR Report Key: 10684394
• Report Number: 3002879653-2020-00007
• Device Sequence Number: 3208199
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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: Life Threatening