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	04/24/2026
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 regional director of dialysis reported to fresenius that an optiflux 250nre dialyzer was not filling with blood during a patient¿s hemodialysis (hd) treatment.The reported event required the staff to restring the machine with new supplies.Additional information was obtained through follow-up with the clinical manager (cm) from the facility where the event occurred.The cm stated blood was not passing through the dialyzer at the start of a patient¿s treatment.Prior to treatment initiation, the circuit was primed with no issues noted.The patient was utilizing an optiflux f250nre dialyzer with a b.Braun streamline bloodline, and connected to a b.Braun hd machine.After priming was completed, the staff started the patient¿s treatment.While monitoring the start, they saw blood enter the dialyzer but not exit.Only saline was being pushed through the bottom of the device.Approximately forty seconds had elapsed since treatment initiation with no change; blood was not passing through the dialyzer.The staff stopped the blood pump to inspect the setup and check all connections.The connections seemed tight and no leaks were noted.There were no issues with the needles, and nothing was clamped.There were no alarms from the b.Braun machine.There were no reports or allegations of clotting.No visible defects were noted on the dialyzer.After completing their checks without finding a potential cause of the issue, they decided to stop the treatment and replace the setup.The patient¿s blood was not returned.Estimated blood loss (ebl) was 50 to 75 ml.The cm 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 the same machine.The sample was confirmed to be available to be returned for manufacturer evaluation.

• 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 ; 6174175172
• MDR Report Key: 25178874
• Report Number: 0001713747-2026-00200
• Device Sequence Number: 13435062
• Product Code: KDI
• UDI-Device Identifier: 00840861100170
• UDI-Public: 00840861100170
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 07/01/2026

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
• Device Lot Number: 25SU04004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2025
• 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
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 100 KG