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	05/05/2026
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 supplies manager reported a dialyzer blood leak associated with a hemodialysis (hd) treatment.In a follow up, a nurse said the leak occurred immediately at starting the hemodialysis (hd) treatment.The nurse explained that the leak was visually seen as blood was dripping from the side of the dialyzer on the floor from the top seal of the dialyzer.The blood leak was described as being an external blood leak.A fresenius 2008k machine was being.Fresenius bloodlines were being used.Blood leak test strips were not used.There was no damage noted on the dialyzer.There was patient blood loss estimated to be 250cc.There was no patient injury, adverse event or medical intervention required as a result of this event other than the minimal blood loss indicated.The patient finished treatment on a the same machine with new supplies.The device is available to be returned to the manufacturer for evaluation.
Event or Problem Description
A supplies manager reported a dialyzer blood leak associated with a hemodialysis (hd) treatment.In a follow up, a nurse said the leak occurred immediately at starting the hemodialysis (hd) treatment.The nurse explained that the leak was visually seen as blood was dripping from the side of the dialyzer on the floor from the top seal of the dialyzer.The blood leak was described as being an external blood leak.A fresenius 2008k machine was being.Fresenius bloodlines were being used.Blood leak test strips were not used.There was no damage noted on the dialyzer.There was patient blood loss estimated to be 250cc.There was no patient injury, adverse event or medical intervention required as a result of this event other than the minimal blood loss indicated.The patient finished treatment on a the same machine with new supplies.The device is available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: d.9.,h.3.Plant investigation:the complaint could not be confirmed, as a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint.A sample was not returned.The third party carrier's website was reviewed and it was verified that the provided shipping materials were sent to the customer and were subsequently received.The report could not be confirmed as a definitive conclusion regarding the complaint incident cannot be reached based on the information provided.A review of the production record was performed.The production record review showed there were multiple approved temporary deviation notice (dn)s in the production of this lot.They are unrelated to the reported complaint event.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.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.

• 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: 25221261
• Report Number: 0001713747-2026-00211
• Device Sequence Number: 9778534
• Product Code: KDI
• UDI-Device Identifier: 00840861100163
• UDI-Public: 00840861100163
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• 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: Health Professional
• Device Catalogue Number: 0500320E
• Device Lot Number: 24AU04010
• 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: 06/09/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2026
• 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 2008K MACHINE; FRESENIUS 2008K MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 75 KG