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

Model Number 710200S

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

Patient Problem Death (1802)

Event Date 08/19/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by user facility: bio-med reported a patient coded and passed away during a treatment.Bio-med verified all the machine safety calibrations and at the time of the incident the dialog machine was operating within specified limits and tolerances.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The customer technician stated that he verified all the machine safety calibrations and that at the time of the incident the machine was operating within b.Braun specified limits and tolerances.The investigation and evaluation of the data sources made available by the customer leads to the conclusion there was no product deviation.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: DIALOG+
• Type of Device: DIALYZER, HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• MDR Report Key: 10454479
• MDR Text Key: 204382216
• Report Number: 3002879653-2020-00005
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• Combination Product (y/n): N
• PMA/PMN Number: K083460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 710200S
• Device Catalogue Number: 710200S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other