MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F250NRe HF 12/CS 2.5SA EBEAM; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	0500325E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A dialysis manager reported to fresenius that a dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.Additional information was obtained through follow-up.The blood leak occurred a little over one hour into the treatment.The blood leak was reported to be internal, and it was confirmed to be visually observed.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.A blood leak test strip was not used.There was no damage or defect noted on the dialyzer.Fresenius bloodlines were also being used.After the leak occurred, the lines were clamped off and the treatment was stopped.The patient¿s blood was not returned; estimated blood loss (ebl) was 200 to 250 ml.It was confirmed there was no patient serious injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The sample was not available to be returned for manufacturer evaluation as it was reportedly discarded.

• Brand Name: OPTIFLUX F250NRe HF 12/CS 2.5SA 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: 25691375
• Report Number: 0001713747-2026-00261
• Device Sequence Number: 18504917
• Product Code: KDI
• UDI-Device Identifier: 00840861100170
• UDI-Public: 00840861100170
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/30/2026

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: 0500325E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
• Patient Sex: Unknown