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

Model Number 710200L

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/03/2022

Event Type  Injury  

Event Description

As reported by the user facility: it was reported that a venous needle dislodged without alarm during treatment.Staff reported the machine never alarmed and blood pump did not stop.The trend file was captured and was provided for evaluation.Upon review of the trend data, it was confirmed that the device did alarm for venous pressure.A safety inspection performed on the device showed no issues.The patient involved in the incident required a blood infusion and was sent to the emergency room for treatment after the event.The customer also confirmed via additional inquiry there was no serious injury and no patient harm was reported after the incident.Estimated time of the occurrence is between one hour and thirteen minutes and one hour and fourteen minutes into the infusion.

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report number (b)(4).The investigation is ongoing at this time.When additional information does become available, a follow-up report will be submitted.

• Brand Name: DIALOG®
• Type of Device: HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• MDR Report Key: 15665556
• MDR Text Key: 302334481
• Report Number: 2521402-2022-00140
• 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: 06/01/2022,10/25/2022

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: 06/01/2022
• Device Age: 9 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other