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	02/11/2026
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 inventory manager reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.Additional information was obtained during follow-up with a facility registered nurse (rn).The reported issue occurred immediately after the initiation of treatment.The blood leak was noted as being an internal blood leak.The leak was visually observed within the dialyzer.The fresenius 2008k2 machine alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 250 ml.There was no patient injury or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Event or Problem Description
A user facility inventory manager reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.Additional information was obtained during follow-up with a facility registered nurse (rn).The reported issue occurred immediately after the initiation of treatment.The blood leak was noted as being an internal blood leak.The leak was visually observed within the dialyzer.The fresenius 2008k2 machine alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 250 ml.There was no patient injury or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: a dialyzer from the reported lot was returned for evaluation.During gross visual examination, a potted fiber fragment was observed at approximately 120°, with the dialysate ports at 0°, on the non-cavity id end.Under magnification of 20x, the fiber fragment measured approximately 0.35mm in length.An opposing end was not identified.There was no other damage or irregularities noted on the returned sample.The reported issue is confirmed.The probable causes for this failure to occur are related to the handling of the fiber bundle during production and during the insertion process of the fiber bundle into the dialyzer housing.A review of the production record was performed.One non-conformance was opened during the production of this lot for exceeding the bubble point rejection rate.All discrepant product was discarded.There was no other indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of the highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via the nc/capa program, in order to assess and improve our products and processes.Capas for vision systems and blood leak reduction are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

• 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: 24377226
• Report Number: 0001713747-2026-00085
• Device Sequence Number: 5650481
• Product Code: KDI
• UDI-Device Identifier: 00840861100170
• UDI-Public: 00840861100170
• Combination Product (Y/N): N
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2026

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: 25LU04024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 05/28/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/22/2026; 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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 2008K2 MACHINE; FRESENIUS 2008K2 MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Race: White