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	12/11/2025
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 clinical care advisor reported to fresenius that a dialyzer blood leak occurred during the patient's treatment.The reported issue occurred approximately 10 minutes after treatment initiation on the fresenius 5008 machine.The blood leak was external.The nurse visually observed blood streaking along the entire length of the dialyzer originating from the arterial cap.The arterial blood inlet tubing was intact.Possible cracks at the level of the cap were suspected.The patient's estimated blood loss (ebl) was approximately 300 ml.No serious injury or required medical intervention resulted from the reported issue.It was stated the bloodlines were discarded and treatment continued on a different machine.The sample was not reported to be available to be returned to the manufacturer for physical evaluation.
Event or Problem Description
A clinical care advisor reported to fresenius that a dialyzer blood leak occurred during the patient's treatment.The reported issue occurred approximately 10 minutes after treatment initiation on the fresenius 5008 machine.The blood leak was external.The nurse visually observed blood streaking along the entire length of the dialyzer originating from the arterial cap.The arterial blood inlet tubing was intact.Possible cracks at the level of the cap were suspected.The patient's estimated blood loss (ebl) was approximately 310 ml.No serious injury or required medical intervention resulted from the reported issue.It was stated the bloodlines were discarded and treatment continued on a different machine with a new dialyzer.The sample was not reported to be available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: a1 (patient identifier), b5 (event description), e1 (initial reporter) the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Additional Manufacturer Narrative
Plant investigation: no sample was returned to the manufacturer for physical evaluation.However, there were two photographs provided for review.Both photographs show the area where the header is threaded onto the housing, but from slightly different angles.In the photos blood is visible in the threads of the header cap.On the section of the header cap that is visible, there does not appear to be any cracks.The reported issue is confirmed.Probable causes for this issue include potential causes of header leaks include be damage to the threads, cracked header caps, and pu build up on the threads causing torque not to be met, a pu sliver under the o-ring, or a damaged o-ring.It is unknown what caused the leak.An investigation of the device history records (dhr) was conducted by the manufacturer.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.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.
Event or Problem Description
A clinical care advisor reported to fresenius that a dialyzer blood leak occurred during the patient's treatment.The reported issue occurred approximately 10 minutes after treatment initiation on the fresenius 5008 machine.The blood leak was external.The nurse visually observed blood streaking along the entire length of the dialyzer originating from the arterial cap.The arterial blood inlet tubing was intact.Possible cracks at the level of the cap were suspected.The patient's estimated blood loss (ebl) was approximately 310 ml.No serious injury or required medical intervention resulted from the reported issue.It was stated the bloodlines were discarded and treatment continued on a different machine with a new dialyzer.The sample was not reported to be available to be returned to the manufacturer for physical evaluation.

• 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: 23877041
• Report Number: 0001713747-2025-01017
• Device Sequence Number: 20000888
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2026

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: 25LU04006
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 01/16/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/05/2026; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2025
• 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 5008S MACHINE; FRESENIUS 5008S MACHINE; FRESENIUS 5008S MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 62 KG