MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE HOLDINGS, INC. OPTIFLUX® ULTRA; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	0500418E
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Head of dialyzer found to be leaking onto the floor which appeared to be leaking at the seal.

• Brand Name: OPTIFLUX® ULTRA
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE HOLDINGS, INC.; 920 winter street; waltham MA 02451
• MDR Report Key: 16303358
• Report Number: 16303358
• Device Sequence Number: 12460412
• Product Code: KDI
• UDI-Device Identifier: 00840861100194
• UDI-Public: (01)00840861100194
• 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): 01/04/2023
• Report Date (Section F): 01/04/2023

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: 0500418E
• Device Lot Number: KU01005
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2023
• 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: 66 KG
• Date Report Sent to FDA: 01/04/2023