MAUDE Adverse Event Report: B.BRAUN AVITUM AG DIALOG+ EVOLUTION HEMODIALYSIS SYSTEM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 710200K & 710200L

Device Problems Defective Alarm (1014); Loose or Intermittent Connection (1371); Air/Gas in Device (4062)

Patient Problem Chest Pain (1776)

Event Date 03/30/2023

Event Type  malfunction  

Event Description

Patient complained of chest pain during rinse back part of treatment.The ccht (certified clinical hemodialysis technician) noticed that there was air in the lines.There was noted to be a loose connection in the tubing between the arterial and saline lines.The dialysis safety air detector did not alarm with the presence of air in the lines.

• Brand Name: DIALOG+ EVOLUTION HEMODIALYSIS SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): B.BRAUN AVITUM AG; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 16784406
• MDR Text Key: 313730300
• Report Number: 16784406
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 710200K & 710200L
• Device Catalogue Number: 710200K & 710200L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Device Age: 9 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10950 DA
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: Black Or African American