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 Problems Arrhythmia (1721); Bradycardia (1751)

Event Date 09/30/2022

Event Type  malfunction  

Event Description

As reported by the user facility: customer reported that the patient coded on the machine while in therapy.

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.

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+®
• 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 ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15639634
• MDR Text Key: 302086083
• Report Number: 3002879653-2022-00112
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• 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
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other