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	12/22/2025
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
It was reported that an external dialyzer blood leak occurred approximately one hour and thirty minutes after the start of a patient¿s hemodialysis (hd) treatment.The attending nurse noticed a pool of blood on the floor.The blood leak appeared to originate from the arterial base of the dialyzer (between the cylindrical portion and the flat surface where the seal is located).No machine alarm occurred.Observable damage was noted on the dialyzer; a photo was provided as evidence.During the priming phase, there was no leakage observed on the floor.The patient¿s blood was not returned.Total blood loss was estimated to be 320cc to 340cc.The extracorporeal circuit had to be discarded, resulting in blood loss of approximately 300cc, and approximately 20 to 40cc of blood leaked onto the floor.The physician had to be contacted, and intravenous antibiotics were administered post-dialysis, along with follow-up blood tests at the subsequent dialysis session.It was confirmed that the antibiotics were administered as a prophylactic measure.There were no reports of a serious patient injury or any adverse effects.The patient was able to complete their treatment after being re-setup with new supplies on the same machine.The sample was not available to be sent back for manufacturer evaluation.
Event or Problem Description
It was reported that an external dialyzer blood leak occurred approximately one hour and thirty minutes after the start of a patient¿s hemodialysis (hd) treatment.The attending nurse noticed a pool of blood on the floor.The blood leak appeared to originate from the arterial base of the dialyzer (between the cylindrical portion and the flat surface where the seal is located).No machine alarm occurred.Observable damage was noted on the dialyzer; a photo was provided as evidence.During the priming phase, there was no leakage observed on the floor.The patient¿s blood was not returned.Total blood loss was estimated to be 320cc to 340cc.The extracorporeal circuit had to be discarded, resulting in blood loss of approximately 300cc, and approximately 20 to 40cc of blood leaked onto the floor.The physician had to be contacted, and intravenous antibiotics were administered post-dialysis, along with follow-up blood tests at the subsequent dialysis session.It was confirmed that the antibiotics were administered as a prophylactic measure.There were no reports of a serious patient injury or any adverse effects.The patient was able to complete their treatment after being re-setup with new supplies on the same machine.The sample was not available to be sent back for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: the complaint device was not available to be returned for manufacturer evaluation.However, two photos were provided for review.The first photo shows one end of the dialyzer connected to a machine and bloodlines.There was blood collected on the rim of the header cap and some blood could be seen on the clinic floor, underneath the dialyzer.The second photo shows the label from the reported lot and catalog number, connected to the machine and bloodlines.Blood collected on the rim of the header cap is indicative of an external blood leak.However, a specific cause of the leak was not visible in the photos.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 was one non-conformance (nc) in the production of the lot which was unrelated to the reported complaint event.There was no indication of product nonacceptance, deviation, nc, 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 leak was confirmed based on the provided photos.However, the cause cannot be determined as the actual sample was not returned for evaluation.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: 24024446
• Report Number: 0001713747-2026-00025
• Device Sequence Number: 13399356
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 25JU04020
• 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: 01/13/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2025
• 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 5008 MACHINE; FRESENIUS 5008 MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 122 KG