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	02/05/2026
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
It was reported that an external dialyzer blood leak occurred during a patient's hemodialysis (hd) treatment.The blood leak occurred approximately twenty minutes into the treatment.Blood was observed to be leaking from the joint located at the end of the dialyzer.There was no visible damage or defect noted at the leak location.There were no alarms from the machine, a fresenius 5008.Upon detection of the leak, the treatment was stopped.The patient's blood was not returned; estimated blood loss (ebl) was 150 ml.There was no indication that the patient experienced a serious injury or required medical intervention due to the blood loss.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.
Event or Problem Description
It was reported that an external dialyzer blood leak occurred during a patient's hemodialysis (hd) treatment.The blood leak occurred approximately twenty minutes into the treatment.Blood was observed to be leaking from the joint located at the end of the dialyzer.There was no visible damage or defect noted at the leak location.There were no alarms from the machine, a fresenius 5008.Upon detection of the leak, the treatment was stopped.The patient's blood was not returned; estimated blood loss (ebl) was 150 ml.There was no indication that the patient experienced a serious injury or required medical intervention due to the blood loss.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.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.No caps were on the dialyzer ports.A sticker with a barcode was present on the housing.Blood was noted throughout the dialyzer, including in the threads of the header cap on the cavity id end.During gross visual examination, a polyurethane (pu) sliver was observed in the header at approximately 175°, with the dialysate ports at 0°, on the cavity id end.The pu sliver was lying across the pu cut surface and was reaching past the o-ring when the header cap was on the dialyzer.Further examination of the complaint device did not identify any other damage or irregularities.The sample was not subjected to a laboratory leak test as a pu sliver is known to affect the integrity of the dialyzer and cause a leak.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was then conducted by the manufacturer.There was one non-conformance (nc) in the production of this lot which was unrelated to the complaint event.There was no other indication of product nonacceptance, deviation, nc, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.The investigation into the complaint was able to confirm the reported event.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: 24524734
• Report Number: 0001713747-2026-00109
• Device Sequence Number: 18273378
• 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): 05/13/2026

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: 25NU04001
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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 5008 MACHINE; FRESENIUS 5008 MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 50 KG