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	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
A user facility reported to fresenius medical care canada that a blood leak occurred two hours and fifty-two minutes after the initiation of the patient¿s hemodialysis (hd) treatment.It was not clear if the leak originated from the dialyzer or the bloodline.The patient¿s estimated blood loss (ebl) is unknown.The complaint device is not available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.However, two photographs were provided by the customer.The photographs both showed a blood port leak coming from the dialyzer where the blood lines are connected.It is unknown what caused the blood leak as there was no damage visible in the pictures.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 one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.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 based on the provided photographs.
Event or Problem Description
A user facility reported to fresenius medical care canada that a blood leak occurred two hours and fifty-two minutes after the initiation of the patient¿s hemodialysis (hd) treatment.It was not clear if the leak originated from the dialyzer or the bloodline.The patient¿s estimated blood loss (ebl) is unknown.The complaint device is not available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.

• 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: 24778376
• Report Number: 0001713747-2026-00146
• Device Sequence Number: 6065712
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 25PU04005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown