MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F200NRE HF 12/CS 1.9SA EBEAM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	0500320E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/05/2026
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 corporate inventory manager reported to fresenius that a dialyzer blood leak occurred at a hemodialysis (hd) user facility.Additional information was obtained through follow-up with a registered nurse (rn) from the facility who was familiar with the event.The blood leak, which was external, was noticed approximately one hour into a patient¿s hd treatment.A technician noticed blood leaking from the arterial header of the device while passing by.There were no alarms from the machine.There was no visible damage or defect noted on the dialyzer, including at/near the leak location.After the leak was noticed, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was 250 to 300 ml.The rn 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 not available to be returned for manufacturer evaluation as it was reportedly discarded.
Event or Problem Description
A corporate inventory manager reported to fresenius that a dialyzer blood leak occurred at a hemodialysis (hd) user facility.Additional information was obtained through follow-up with a registered nurse (rn) from the facility who was familiar with the event.The blood leak, which was external, was noticed approximately one hour into a patient¿s hd treatment.A technician noticed blood leaking from the arterial header of the device while passing by.There were no alarms from the machine.There was no visible damage or defect noted on the dialyzer, including at/near the leak location.After the leak was noticed, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was 250 to 300 ml.The rn 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 not available to be returned for manufacturer evaluation as it was reportedly discarded.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.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 F200NRE HF 12/CS 1.9SA 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: 24394720
• Report Number: 0001713747-2026-00087
• Device Sequence Number: 18287641
• Product Code: KDI
• UDI-Device Identifier: 00840861100163
• UDI-Public: 00840861100163
• 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
• Report Date (Section B): 03/25/2026

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: 0500320E
• Device Lot Number: 25LU04013
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2025
• 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 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 76 KG