MAUDE Adverse Event Report: FRESENIUS USA, INC. 2008® SERIES HEMODIALYSIS MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	190630
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patients machine alarmed.Registered nurse (rn) got the air out of the venous chamber and treatment was continued.The machine alarmed again, for the air detector.Lines were observed and a small incision in the tubing around the blood pump was noted.The machine was switched out and an entire new system was placed.

• Brand Name: 2008® SERIES HEMODIALYSIS MACHINES
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS USA, INC.; 920 winter street; waltham MA 02451
• MDR Report Key: 16688852
• Report Number: 16688852
• Device Sequence Number: 7396984
• Product Code: KDI
• UDI-Device Identifier: 00840861100866
• UDI-Public: (01)00840861100866
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/15/2023
• Report Date (Section F): 03/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: 190630
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 76 KG
• Date Report Sent to FDA: 03/15/2023