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

Model Number	190858
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
When the patient was connected to the hemodialysis machine the machine was alarming high conductivity, not reading transmembrane pressure (tmp), and said low flow error.There was an attempt to reset the machine, but due to high pressures that were not reading and no tmp reading the patient's venous site on the left av fistula infiltrated.

• 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: 13794847
• Report Number: 13794847
• Device Sequence Number: 11769707
• Product Code: KDI
• UDI-Device Identifier: 00840861100903
• UDI-Public: (01)00840861100903
• 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): 03/03/2022
• Report Date (Section F): 03/03/2022

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: 190858
• Device Lot Number: 2008T
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 03/03/2022