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	04/28/2026
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 risk manager reported, through a medwatch report (5187562), that there was a dialyzer blood leak during a hemodialysis (hd) treatment.Additional information was received from a dialysis technician the leak occurred immediately at starting the hemodialysis (hd) treatment when the blood hit the dialyzer.The nurse explained that the leak was visually seen toward the head of the dialyzer¿in dialysate compartment.The blood leak was described as being an internal blood leak.A fresenius 2008t machine was being used.Fresenius bloodlines were being used.Blood leak test strips were not used.There was no damage noted on the dialyzer.There was patient blood loss estimated to be 88cc.There was no patient injury, adverse event or medical intervention required as a result of this event other than the minimal blood loss indicated.The patient finished treatment on a the same machine with new supplies.The device is not available to be returned to the manufacturer for 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: 25291835
• Report Number: 0001713747-2026-00214
• Device Sequence Number: 21273746
• Product Code: KDI
• UDI-Device Identifier: 00840861100170
• UDI-Public: 00840861100170
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: 25PU04011
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS COMBISET BLOODLINES
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 91 KG