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	01/29/2026
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
The facility administrator (fa) reported to fresenius that a dialyzer blood leak occurred during the patient's hemodialysis (hd) treatment.The blood leak was noted to be external.The blood leak was identified approximately 15 minutes after treatment initiation.Blood was visually observed leaking from the arterial head of the dialyzer near the hansen connection.The leak appeared to be coming out of the threads of the connector.No defect or damage was noted to the dialyzer.Treatment was paused.The patient's blood was returned.The patient's estimated blood loss (ebl) was not quantified but defined as "small." no serious injury or required medical intervention resulted from the reported issue.Treatment was completed on a different machine with new supplies.The sample is available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: a sample from the reported lot number was returned for evaluation.The dialyzer was subjected to a laboratory leak test and no leaks were detected.Upon removal of the header cap, the polyurethane (pu) cut surface was found to be damaged, at approximately 45°, with the ports positioned at 0° on the non-cavity id end.The damage was in the form of a scrape along the cut surface and is located where the o-ring would make contact with the pu surface.No other damage or irregularities were noted on the returned sample.The reported issue was confirmed.The probable causes for this damage include: cutter chips in the half shell, could cause the dialyzer to lift and get hit by the upper half shell, or misalignment of the cap or collar remover.A review of the production record was performed.There was no 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.
Event or Problem Description
The facility administrator (fa) reported to fresenius that a dialyzer blood leak occurred during the patient's hemodialysis (hd) treatment.The blood leak was noted to be external.The blood leak was identified approximately 15 minutes after treatment initiation.Blood was visually observed leaking from the arterial head of the dialyzer near the hansen connection.The leak appeared to be coming out of the threads of the connector.No defect or damage was noted to the dialyzer.Treatment was paused.The patient's blood was returned.The patient's estimated blood loss (ebl) was not quantified but defined as "small." no serious injury or required medical intervention resulted from the reported issue.Treatment was completed on a different machine with new supplies.The sample is available to be returned to the manufacturer for physical 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: 24246604
• Report Number: 0001713747-2026-00058
• Device Sequence Number: 9618366
• 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): 03/06/2026

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: 25LU04017
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2025
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 78 KG