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	06/10/2026
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 user facility nurse reported that a dialyzer blood leak occurred approximately three hours after the start of treatment.The blood leak was reported to be external.The blood leak (as described) was coming from the connection of the header/end-cap to the body of the device, as depicted in a provided diagram.No alarm occurred.The machine in use was a fresenius 5008.Fresenius bloodlines were also in use.There was no damage observed on the dialyzer.It was reportedly not possible to quantify the amount of blood loss the patient experienced.The patient did not complete their treatment; they ran for three hours instead of four hours.There was no report of any serious patient injury or harm due to the blood leak event.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 ; +1(617)417-5172
• MDR Report Key: 25619590
• Report Number: 0001713747-2026-00248
• Device Sequence Number: 10134662
• Product Code: KDI
• UDI-Device Identifier: 00840861100170
• UDI-Public: 00840861100170
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: 26BU04002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• 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: 06/12/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2026
• 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 5008 MACHINE.; FRESENIUS BLOODLINES.
• Patient Sex: Male
• Patient Weight: 184 LB