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

Model Number	710200L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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®
• Common Device Name: HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• MDR Report Key: 15665556
• Report Number: 2521402-2022-00140
• Device Sequence Number: 20625355
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2022
• Report Date (Section F): 06/01/2022

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
• Operator of Device: 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
• Device Age: 9 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/01/2022