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 Code	Hemolysis (1886)
Date of Event	12/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the user facility: customer reported that they had a patient issue with hemolysis looking at the machine data for the treatment it indicated low pressure during therapy however the staff indicated high pressure.The customer has completely verified functionality of the machine.Blood handling pressure sensors along with conductivity and blood pump roller.Unfortunately the staff failed to save the dialyzer and blood tubing.Patient outcome was good but hospitalization was necessary for several days due to the high volume of damaged red blood cells.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The customer reported that they had a patient issue with hemolysis.Customer states that "looking at the machine data for the treatment it indicated low pressure during therapy however the staff indicated high pressure".The customer has completely verified functionality of the machine and the customer stated that there is no indication that the machine caused the incident.The bloodlines and the dialyzer have been discarded.The patient outcome was good but hospitalization for several days was necessary due to the high volume of damaged red blood cells.Investigation: no machine data records were made available for investigation.No answers to our questions nor any further information was provided.Due to the limited information, the case is not comprehensible.In general, hemolysis during dialysis can have several non-machine related causes, e.G.Patient and/or disposable-related.To date, b.Braun has not received any complaints of hemolysis caused by any of its dialog+ dialysis machines.There is no evidence of device-related hemolysis and the customer has confirmed that the machine has no malfunction.All safety-relevant functions are tested during the machine's self-tests in preparation.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
• MDR Report Key: 16340195
• Report Number: 2521402-2023-00005
• Device Sequence Number: 6332289
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2023

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: 710200L
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/10/2023
• Device Age: 13 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2023
• 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: Hospitalization
• Patient Sex: Unknown