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 Codes	Fall (1848); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: based on the available information, a temporal relationship exists between hd therapy utilizing an optiflux 200nre dialyzer, and the serious adverse events of a blood leak resulting in blood loss (approximately 310-360 ml), hypotension and a fall, which require a normal saline bolus to remediate.Per the hdrn, the patient¿s blood was visualized exiting the optiflux 200nre dialyzer where the seal between the flat end of the dialyzer and the cylindrical part connect (no visible damage was noted on the interior/exterior of the optiflux 200nre dialyzer).While uncommon, blood leak events are a known potential complication of utilizing optiflux series dialyzers during hd therapy (1).
Event or Problem Description
On (b)(6) 2026, fresenius became aware this 81-year-old female patient with end stage renal disease (esrd) on hemodialysis (hd) since 2021 for renal replacement therapy (rrt) experienced an optiflux 200nre dialyzer blood leak during hd therapy on (b)(6) 2026.The description of the event revealed that after approximately 2 hours and 20 minutes into treatment, the patient experienced an optiflux 200nre dialyzer blood leak.Although the evidence of the blood leak was visible on the floor, the hanson connectors, and the 5008 hemodialysis system itself, no visible defect was noted.According to the report, the blood leak occurred ¿at the seal between the flat end of the dialyzer and the cylindrical part.¿ once discovered the treatment was discontinued, and the patient¿s extracorporeal blood was discarded (estimated blood loss = 310-360 ml).Although the definitive timeline is unknown, it appears the patient became hypotensive following the blood loss event and sustained a fall to the floor.The patient received a 200 ml bolus of normal saline, hd was restarted with new supplies, and the treatment was completed without any reported issues.There was no report of injury from the patient¿s fall.

• 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 ; +1(617)417-5172
• MDR Report Key: 24580762
• Report Number: 0001713747-2026-00121
• Device Sequence Number: 9157996
• Product Code: KDI
• UDI-Device Identifier: 00840861100163
• UDI-Public: 00840861100163
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0500320E
• Device Lot Number: 25PU04005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2025
• 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 BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 123 LB