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

Catalog Number 710500L

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Insufficient Information (4580)

Event Date 08/08/2020

Event Type  Death  

Manufacturer Narrative

This report has been identified as b. Braun medical inc. Internal report number (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: a fatality occurred during a patient therapy. The caller stated that the belief is this was not a maching issue but a work flow issue. The caller stated he was informed not to provide any details.

• 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
• Manufacturer (Section G): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• Manufacturer Contact: jonathan severino ; 824 12th avenue; bethlehem, pa ; 2408332
• MDR Report Key: 10470853
• MDR Text Key: 204870818
• Report Number: 3002879653-2020-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Catalogue Number: 710500L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2010
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 08/31/2020 Patient Sequence Number: 1