MAUDE Adverse Event Report: B. BRAUN AVITUM AG DIALOG®; HIGH PERMEABILIT

Model Number 710200L

Device Problem Retraction Problem (1536)

Patient Problem Air Embolism (1697)

Event Date 04/20/2022

Event Type  Death  

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: patient pulled /removed tubing from "permacath" feed on their own and the machine did not alarm as reported by the caller.Patient had a permcath central venous catheter.Treatment was on (b)(6) 2022.Start time 13:00 end time 16:10.Service report attached.Line 5.6 on the attached service report indicates that the sad was tested and it functionally passed.Patient became unresponsive and looked as he was having a seizure.He was sent to ct which indicated an extensive cerebral venous gas.Medical intervention apart from sending the patient to the icu: placing in trendelenburg position and high flow oxygenation.Patient disconnected himself from dialysis at the connection site where the dialysis tubing attaches to the portcath arterial port.Braun streamline airless system set for b.Braun dialog machines was used.Patient outcome: family elected to withdrawal care, and patient expired.Diagnosis in the icu: acute embolism stroke.

• Brand Name: DIALOG®
• Type of Device: 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: 14401311
• MDR Text Key: 291700676
• Report Number: 2521402-2022-00031
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2022

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: 04/21/2022
• Initial Date FDA Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2017
• 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): Death
• Patient Sex: Male