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

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.

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 machine issue but a work flow issue.The caller stated he was informed not to provide any details.Additional information received via medwatch 5096218.Per the information on the medwatch: citric acid used in place of bicarbonate.B.Braun dialog dialysis machine sw 9.1x does not have built in ph meter and allowed user to continue administering dialysis without checking ph.

• Brand Name: DIALOG+
• Type of Device: HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• MDR Report Key: 10470852
• MDR Text Key: 204877635
• Report Number: 2521402-2020-00006
• Device Sequence Number: 1
• Product Code: KDI
• 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: 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
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 710500L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2020
• Distributor Facility Aware Date: 08/25/2020
• Device Age: 10 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other