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

Model Number 710200L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2023

Event Type  Death  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).We were informed that a patient died during dialysis therapy.The patient was on a ventilator in icu.Investigation upon further enquiry, the customer did not provide any further information.A cause of death was not disclosed.No machine data records were made available for investigation.The dialog+ dialysis machine was inspected by a customer's technician.The inspection did not show a malfunction, the machine operated as intended.There was 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.Since there was no product deviation, no further action will be taken.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by the user facility: customer states that he was told by his facility's safety officer that the dialysis nurse left the patient room to use the restroom, and that when she returned the patient's ventilator was alarming so she called for help from the icu staff.Patient had been made a dnr earlier in the day so no acls was performed at this time, and patient expired.Patient was then removed from the dialysis machine.

• Brand Name: DIALOG+®
• Type of Device: 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: 16406010
• MDR Text Key: 309854117
• Report Number: 3002879653-2023-00003
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 710200L
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death