MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F180NR HF 12/CS 1.7SA ETO; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	0500318N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility nurse reported that a dialyzer blood leak occurred fifteen minutes into a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow-up with a patient care technician (pct) from the facility who was familiar with the event.The pct stated blood was observed leaking externally from the arterial head of the dialyzer.The leak seemed to be coming through the threading where the head screws on.There were no machine alarms.No visible damage or defects were noted on the dialyzer.After the blood leak was identified, the blood pump was stopped and the patient¿s blood was returned.The patient¿s estimated blood loss (ebl) due to the leak was less than 50 ml.The pct 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 confirmed to be available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The dialyzer was returned with the corporate provided caps attached.The fibers were wet with blood, with blood in the threads of the header cap on the cavity id end.A polyurethane (pu) sliver was found on the cavity id end, at approximately 140°, with the dialysate ports positioned at 0°.The pu sliver extended under the o-ring.Further examination of the complaint device did not identify any other damage or irregularities.The dialyzer was not subjected to a 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 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.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.
Event or Problem Description
A user facility nurse reported that a dialyzer blood leak occurred fifteen minutes into a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow-up with a patient care technician (pct) from the facility who was familiar with the event.The pct stated blood was observed leaking externally from the arterial head of the dialyzer.The leak seemed to be coming through the threading where the head screws on.There were no machine alarms.No visible damage or defects were noted on the dialyzer.After the blood leak was identified, the blood pump was stopped and the patient¿s blood was returned.The patient¿s estimated blood loss (ebl) due to the leak was less than 50 ml.The pct 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 confirmed to be available to be returned for manufacturer evaluation.

• Brand Name: OPTIFLUX F180NR HF 12/CS 1.7SA ETO
• 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: 24500370
• Report Number: 0001713747-2026-00104
• Device Sequence Number: 13251835
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K002277
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 0500318N
• Device Lot Number: 25LU04018
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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: 87 YR
• Patient Sex: Male
• Patient Weight: 87 KG