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	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility patient care technician (pct) noted approximately 5-10 minutes into treatment a weird pattern on dialyzer fibers.Upon follow up, the clinic manager reported that the weird pattern appeared to be a blood clot traveling outside of the fibers.The clinic manager stated that the machine, a fresenius 2008t machine with serial number (b)(6), did not alarm with a blood leak alarm and was pulled from service.The machine was fixed and returned to service but it is unknown if the blood leak detector needed to be calibrated, cleaned, or replaced.Blood leak test strips were used and tested positive.The leak was not visually observed just the weird pattern on the dialyzer fibers.Fresenius bloodlines were used for treatment.The clinic manager reported that the leak was internal.There was no defect or damage seen on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 200 ml.There was no patient injury or medical intervention required as a result of the reported event.The patient was restarted on a different machine and treatment completed successfully with new supplies.The clinic manager stated that the dialyzer is available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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: 25860642
• Report Number: 0001713747-2026-00283
• Device Sequence Number: 12078870
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2026

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: 26DU06002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2026
• 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: 07/03/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2026
• 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: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 160 LB