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
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).It was reported that during therapy a patient coded and was sent to the hospital.The customer stated that the machine had no fault and worked as intended.He did not want to file a complaint either.Investigation: no machine data records were made available for investigation.No answers to our questions nor any further information was provided.Investigation has been performed based on the available information and data: as reported, a technician at the customer's site checked the machine and found that it was working as intended.There is no product deviation.All safety-relevant functions are tested during the machine's self-tests in preparation.A therapy cannot be started without passing the self-tests.If a safety-relevant defect occurs during therapy the machine triggers an alarm and switches to patient-safe mode.The complaint data received shows no evidence of device malfunction.There is no product deviation.If additional pertinent information becomes available a follow-up report will be filed.

• 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4047197287
• MDR Report Key: 16372847
• Report Number: 3002879653-2023-00002
• Device Sequence Number: 12451971
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown