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	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility registered nurse (rn) reported that a dialyzer blood leak occurred at the initiation of a patient¿s hemodialysis (hd) treatment.The blood leak was reported to be internal, and blood was confirmed to be visually observed outside of the fibers.The machine, a fresenius 2008t machine, did not alarm with a blood leak alert.The rn explained that the machine alarm did not go off because of how quickly the blood leak was caught.The blood pump was stopped immediately after they noticed.A blood leak test strip was not used as it was deemed unnecessary.There was no damage or defect noted on the dialyzer.Fresenius bloodlines were also being used.The patient¿s blood was not returned.The rn said the patient¿s 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 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 fibers were wet with blood residue present.Corporate provided blood port and adapter caps were attached to the dialyzer.There was no damage noted on the returned sample.A laboratory bubble point leak test was performed on the returned sample.A leak was detected on the non-cavity id end at approximately 300°, with the dialysate ports situated at 0°.The dialyzer was then subjected to destructive disassembly for further visual examination.Upon extraction of the fiber bundle, a kinked fiber and a looped fiber were found.It was noted that the ends of kinked and looped fibers were potted on the same side; however, the looped fiber looped back down on one end back into the dialyzer housing.The smaller fiber measured 0.75 inches from the potting surface.Further examination of the complaint device did not identify any other damage or irregularities.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 registered nurse (rn) reported that a dialyzer blood leak occurred at the initiation of a patient¿s hemodialysis (hd) treatment.The blood leak was reported to be internal, and blood was confirmed to be visually observed outside of the fibers.The machine, a fresenius 2008t machine, did not alarm with a blood leak alert.The rn explained that the machine alarm did not go off because of how quickly the blood leak was caught.The blood pump was stopped immediately after they noticed.A blood leak test strip was not used as it was deemed unnecessary.There was no damage or defect noted on the dialyzer.Fresenius bloodlines were also being used.The patient¿s blood was not returned.The rn said the patient¿s 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 confirmed to be available to be returned for manufacturer evaluation.

• 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: 24562501
• Report Number: 0001713747-2026-00114
• Device Sequence Number: 15851435
• Product Code: KDI
• UDI-Device Identifier: 00840861100163
• UDI-Public: 00840861100163
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: 25NU04008
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2025
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 73 KG