MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F18NRE DIALYZER FINISHED ASSY; DIALYZER, CAPILLARY, HOLLOW FIBER

Catalog Number	0500318E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A registered nurse (rn) reported a dialyzer blood leak associated with hemodialysis (hd) treatment.In a follow up, the nurse reported that the blood leak occurred about 2 hours into the hd treatment.The nurse explained that the leak was not visually seen.The blood leak was described as being an internal blood leak.A fresenius 2008t machine was being used.The machine did alarm appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.Fresenius bloodlines were used.There was no damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was 200 ml.There was no patient injury, adverse event or medical intervention required as a result of this event.The treatment was completed on the same machine with new supplies.The device is not available to be returned to the manufacturer for evaluation.
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 registered nurse (rn) reported a dialyzer blood leak associated with hemodialysis (hd) treatment.In a follow up, the nurse reported that the blood leak occurred about 2 hours into the hd treatment.The nurse explained that the leak was not visually seen.The blood leak was described as being an internal blood leak.A fresenius 2008t machine was being used.The machine did alarm appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.Fresenius bloodlines were used.There was no damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was 200 ml.There was no patient injury, adverse event or medical intervention required as a result of this event.The treatment was completed on the same machine with new supplies.The device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Correction: d.4.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 number of complaints for the assigned symptom code on the lot number was reviewed and it was determined that no lot complaint excursion occurred.A review of the production record was performed.The production record review showed five of the 12 identified lots had one to multiple approved temporary deviation notices.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 F18NRE DIALYZER FINISHED ASSY
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• 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: 23080086
• Report Number: 0001713747-2025-00654
• Device Sequence Number: 9812233
• Product Code: FJI
• UDI-Device Identifier: 00840861100088
• UDI-Public: 00840861100088
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 0500318E
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE.; FRESENIUS 2008T MACHINE.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 80 KG