MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG+; HIGH PERMEABILITY

Model Number 710200L

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

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 05/30/2020

Event Type  Death  

Event Description

As reported by user facility: patient complained of shortness of breath (sob) during treatment and was taken off treatment early.Patient's oxygen saturation level dropped below 88%.Once the blood was returned the patient coded and passed away.

Event Description

This report has been identified as b.Braun medical inc.Internal report#: (b)(4).This follow-up report is being filed for corrections.Section b2 has been changed.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: DIALOG+
• Type of Device: HIGH PERMEABILITY
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• MDR Report Key: 10137247
• MDR Text Key: 194607776
• Report Number: 2521402-2020-00004
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 710200L
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2020
• Distributor Facility Aware Date: 06/01/2020
• Device Age: 21 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other