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 Codes	Arrhythmia (1721); Bradycardia (1751)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: customer reported that the patient coded on the machine while in therapy.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).It was reported that a patient coded when treated with the above mentioned dialog+ dialysis machine.Upon further inquiry, it was reported that the patient coded 47 minutes after therapy start.The blood in the extracorporeal circuit was returned to the patient, cpr was administered.Until the time when the patient coded, the dialysis treatment ran without any issue.The customer's technician inspected the dialog+ dialysis machine.There was no malfunction, the dialysis machine operated as intended.Healthcare providers present during the patient incident did not attribute the code to a malfunction of the dialog+ machine.The customer sent a fsu stick where the data record of the dialog+ machine was intended to be, but the stick provided was empty.Thus, the data record of the dialysis machine was not available for investigation.Since the technical inspection of the dialog+ machine did not show any malfunction and it operated as intended, no further action will be taken.

• 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 ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15639634
• Report Number: 3002879653-2022-00112
• Device Sequence Number: 6436303
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: 09/30/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown