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	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A medical center risk manager reported via voluntary medwatch that a hemodialysis (hd) patient utilizing an optiflux f250nre dialyzer experienced a dialyzer blood leak.The blood leak reportedly occurred at the initiation of treatment, when blood hit the arterial side of the dialyzer.The machine alarmed immediately with a blood leak alarm.The blood leak was reported to be visually observed.The treatment was stopped, and blood was not returned to the patient.The patient was disconnected from the setup.The patient¿s estimated blood loss (ebl) was <100ml.Due to the blood loss, the doctor was notified.The patient was relocated to a different machine to continue their treatment.There was no indication that the patient experienced a serious injury, any adverse effects, or that medical intervention was required.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Plant investigation: the complaint device was not returned for manufacturer evaluation.Furthermore, a valid lot number for the device was not provided.A shipping history search for dialyzers delivered to the account could not be performed because an account number was not identified.As such, a device history review (dhr) and manufacturing review could not be performed.A definitive conclusion regarding the complaint incident could not be reached and the complaint is not confirmed.
Event or Problem Description
A medical center risk manager reported via voluntary medwatch that a hemodialysis (hd) patient utilizing an optiflux f250nre dialyzer experienced a dialyzer blood leak.The blood leak reportedly occurred at the initiation of treatment, when blood hit the arterial side of the dialyzer.The machine alarmed immediately with a blood leak alarm.The blood leak was reported to be visually observed.The treatment was stopped, and blood was not returned to the patient.The patient was disconnected from the setup.The patient¿s estimated blood loss (ebl) was <100ml.Due to the blood loss, the doctor was notified.The patient was relocated to a different machine to continue their treatment.There was no indication that the patient experienced a serious injury, any adverse effects, or that medical intervention was required.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.

• 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: 24594849
• Report Number: 0001713747-2026-00123
• Device Sequence Number: 16033788
• Product Code: KDI
• UDI-Device Identifier: 00840861100170
• UDI-Public: 00840861100170
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 0500325E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown