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  

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.

• 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: 9621352
• MDR Text Key: 176047980
• Report Number: 2521402-2020-00001
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2020

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2020
• Distributor Facility Aware Date: 01/07/2020
• Device Age: 14 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other