MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F250NRE HF 12/CS 2.5SA EBEAM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	0500325E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility inventory manager reported a dialyzer blood leak.The estimated blood loss (ebl) was unknown.The sample was available to be returned for evaluation.Additional information was requested but was not received to date.
Additional Manufacturer Narrative
Additional information: a1, a2, a3, a4, b5, d10 concomitant medical product and therapy date codes, h6 device component code.
Event or Problem Description
A user facility inventory manager reported a dialyzer blood leak.The sample was available to be returned for evaluation.Upon follow-up, the clinic manager (cm) stated an external dialyzer blood leak occurred one hour and twenty minutes after initiation of hemodialysis (hd) treatment.The machine, a 2008t, did not alarm as the blood leak was external.The blood leak was visually observed at the dialyzer head.Blood was noted dripping from the clear top of plastic case of the dialyzer, and some small droplets of blood was noted on floor beneath the dialyzer and on the floor.Blood test strips were not used.The patient was utilizing fresenius bloodlines.No damage was noted on the dialyzer prior to treatment.The patient's blood was reportedly returned.The estimated blood loss (ebl) was not provided as the cm reported only two small droplets on the floor beneath the dialyzer was observed.Immediately following the event, the patient was re-setup with new supplies on the same machine and completed treatment without further issue.The machine is back 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.

• Brand Name: OPTIFLUX F250NRE HF 12/CS 2.5SA 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: 25176272
• Report Number: 0001713747-2026-00199
• Device Sequence Number: 16070763
• Product Code: KDI
• UDI-Device Identifier: 00840861100170
• UDI-Public: 00840861100170
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2026

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: Other
• Device Catalogue Number: 0500325E
• Device Lot Number: 25NU04011
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 06/10/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 05/20/2026; 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2025
• 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: 100 KG