MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F180NR HF 12/CS 1.7SA ETO; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	0500318N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/25/2026
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 clinical manager reported that an external dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow-up with a patient care technician (pct) from the facility.The blood leak was first noticed at the beginning of the patient¿s treatment.However, initially there were only trace amounts of blood on the outside of the device.The pct thought the connections weren't tight enough, so they wiped the blood off the device and tightened the connections.About halfway into the treatment, blood was noticed on the floor underneath the dialyzer.At this point, the pct was able to see where the blood was coming from.It was leaking externally from underneath the header cap.There were no alarms from the machine, a fresenius 2008t.There was no physical damage or defect noted on the dialyzer, including at the leak location.The pct stopped the blood pump and did not return the patient¿s blood.Estimated blood loss (ebl) was 250 to 300 ml.The pct confirmed there was no patient serious injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on the same machine.The sample was not available to be returned for manufacturer evaluation as it was reportedly discarded.However, a photo of the device was provided for review.
Event or Problem Description
A user facility clinical manager reported that an external dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow-up with a patient care technician (pct) from the facility.The blood leak was first noticed at the beginning of the patient¿s treatment.However, initially there were only trace amounts of blood on the outside of the device.The pct thought the connections weren¿t tight enough, so they wiped the blood off the device and tightened the connections.About halfway into the treatment, blood was noticed on the floor underneath the dialyzer.At this point, the pct was able to see where the blood was coming from.It was leaking externally from underneath the header cap.There were no alarms from the machine, a fresenius 2008t.There was no physical damage or defect noted on the dialyzer, including at the leak location.The pct stopped the blood pump and did not return the patient¿s blood.Estimated blood loss (ebl) was 250 to 300 ml.The pct confirmed there was no patient serious injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on the same machine.The sample was not available to be returned for manufacturer evaluation as it was reportedly discarded.However, a photo of the device was provided for review.
Additional Manufacturer Narrative
Plant investigation: the complaint device was not available to be returned for manufacturer evaluation.However, a photograph of the device was provided by the clinic.The photo shows the dialyzer from the reported catalog and lot number.There is blood visible within the threads at one end of the dialyzer, which is indicative of an external leak.The specific cause of the leak was not visible in the photo.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was then conducted by the manufacturer.There were multiple approved temporary deviation notices (dns) reported on the lot which were 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 provided photograph indicates that an external leak occurred, however, the cause cannot be determined.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 F180NR HF 12/CS 1.7SA ETO
• 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: 24846676
• Report Number: 0001713747-2026-00158
• Device Sequence Number: 8947081
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K002277
• 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): 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: 0500318N
• Device Lot Number: 25LU04020
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2025
• 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 2008T MACHINE.; FRESENIUS 2008T MACHINE.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 68 KG