MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F160NRe HF 12/CS 1.5SA EBEAM; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	0500316E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility¿s clinic manager (cm) reported that a visible internal dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The machine, a fme 2008h machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used because the leak was visible.A fme bloodline was in use.There was no obvious defect or damage seen on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 125ml.The patient was restarted on the same machine and treatment completed successfully with new supplies.There was no patient injury or medical intervention required due to the reported event.The complaint device is not available to be returned to the manufacturer for evaluation.One photo has been provided.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.However, one photograph was provided by the customer.The photograph showed the dialyzer label from the reported lot number.No damage, defect, or leak was visible in the photograph.A specific cause of the leak was not visible in the photograph.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one non-conformance (nc) in the production of this lot.It is unrelated to the reported complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.The investigation into the complaint was not able to confirm the reported event.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of the highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via the nc/capa program, in order to assess and improve our products and processes.Capas for vision systems and blood leak reduction are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

• Brand Name: OPTIFLUX F160NRe HF 12/CS 1.5SA EBEAM
• Common Device Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; +1(617)417-5172
• MDR Report Key: 50787017
• Report Number: 0001713747-2026-00345
• Device Sequence Number: 9415895
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K162488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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 Catalogue Number: 0500316E
• Device Lot Number: 26DU06028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Supplement Date Received by Manufacturer: 09/26/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FME Bloodlines; FME Hemodialysis Machine
• Patient Sex: Female
• Patient Weight: 138 LB