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

Model Number 710200L

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

Patient Problem No Information (3190)

Event Type  Injury  

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: there was a patient code while on dialysis.Customer does not believe the code was related to the machine.It was reported there were no alarms that would have indicated there was a problem with the machine.Electrolytes, blood cultures and other labs were drawn on the patient.The machine was isolated after the code but has since been put back into service.The customer indicated they are confident the machine was not involved or related in any way to the patient code.No further details on the nature of the patient code or status were provided.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device involved was not received for evaluation.Per the information from the customer, their inquiry was not related to a machine dysfunction.The customer further stated there were no alarms that would have indicated there was a problem with the machine or any product.The machine was isolated after the code but has since been put back into service.If additional pertinent information becomes available a follow-up report will be filed.

• 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: 9621355
• MDR Text Key: 189835800
• Report Number: 3002879653-2020-00001
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (y/n): N
• PMA/PMN Number: K963440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other