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	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.Blood was noted in the threads of the header cap on the non-cavity id end.A polyurethane (pu) sliver was found on the non-cavity id end, at approximately 140°, with the ports positioned at 0°.The pu sliver extended under the o-ring.No other damage or irregularities were noted on the returned sample.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 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.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 facility administrator (fa) stated blood was found to be leaking from the arterial head of the dialyzer.The leak was identified approximately 15 minutes into treatment.Once treatment started and dialyzer was turned arterial side up blood visualized in arterial cap.Treatment was stopped and the patient's blood was returned.A new circuit was set up on the machine.Upon follow-up, the fa stated an external dialyzer blood leak occurred fifteen minutes after initiation of hemodialysis (hd) treatment.The machine, a 2008t, did not alarm with a blood leak alert as the blood leak was external.The blood leak was visually observed from the arterial head of the dialyzer, when the dialyzer was turned arterial side up and blood was visualized leaking from the arterial cap.Blood test strips were not used as the blood leak was visible and external.The patient was utilizing fresenius bloodlines.No damage was noted on the dialyzer prior to treatment.The patient's blood was returned.The estimated blood loss (ebl) was less than 100 ml.Immediately following the event, the patient was re-setup with new supplies on the same machine and completed treatment without further issue.The machine remains in service.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The dialyzer was available to be returned for manufacturer evaluation.
Event or Problem Description
A user facility administrator (fa) stated blood was found to be leaking from the arterial head of the dialyzer.The leak was identified approximately 15 minutes into treatment.Once treatment started and dialyzer was turned arterial side up blood visualized in arterial cap.Treatment was stopped and the patient's blood was returned.A new circuit was set up on the machine.Upon follow-up, the fa stated an external dialyzer blood leak occurred fifteen minutes after initiation of hemodialysis (hd) treatment.The machine, a 2008t, did not alarm with a blood leak alert as the blood leak was external.The blood leak was visually observed from the arterial head of the dialyzer, when the dialyzer was turned arterial side up and blood was visualized leaking from the arterial cap.Blood test strips were not used as the blood leak was visible and external.The patient was utilizing fresenius bloodlines.No damage was noted on the dialyzer prior to treatment.The patient's blood was returned.The estimated blood loss (ebl) was less than 100 ml.Immediately following the event, the patient was re-setup with new supplies on the same machine and completed treatment without further issue.The machine remains in service.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The dialyzer was available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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: 24351500
• Report Number: 0001713747-2026-00081
• Device Sequence Number: 10200438
• 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: 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: 0500318N
• Device Lot Number: 25LU04017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/25/2026
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 97 KG