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	01/06/2026
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 inventory manager reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.Additional information was obtained during follow-up with a user facility nurse.The reported issue occurred upon treatment initiation.The blood leak was noted as being an internal blood leak.The leak was visually observed within the dialyzer.The machine, a fresenius 2008k2 machine, alarmed appropriately with a blood leak alarm.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was defined as "less than 500 ml." there was no patient injury or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: d4, d9, h3, h4.
Event or Problem Description
A user facility inventory manager reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.Additional information was obtained during follow-up with a user facility nurse.The reported issue occurred upon treatment initiation.The blood leak was noted as being an internal blood leak.The leak was visually observed within the dialyzer.The machine, a fresenius 2008k2 machine, alarmed appropriately with a blood leak alarm.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was defined as "less than 500 ml." there was no patient injury or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.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 user facility inventory manager reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.Additional information was obtained during follow-up with a user facility nurse.The reported issue occurred upon treatment initiation.The blood leak was noted as being an internal blood leak.The leak was visually observed within the dialyzer.The machine, a fresenius 2008k2 machine, alarmed appropriately with a blood leak alarm.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was defined as "less than 500 ml." there was no patient injury or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: a sample from lot number 25lu04007 was returned for evaluation which the facility confirmed was the correct sample for this complaint.There was blood present within the threads of the header cap on the non-cavity id end.As it was reported the leak was internal, the dialyzer was subjected to a bubble point test (internal leak test), and no leaks were detected.Furthermore, as there as blood within the threads of the header cap, the dialyzer was then subjected to an external laboratory leak test, and a leak was detected from beneath the non-cavity id end header cap at approximately 14.0psi.Upon removal of the header cap, the polyurethane (pu) cut surface was found to be damaged from approximately 290°, with the dialysate ports positioned at 0°.The damage appeared to be in the form of a scrap or gouge in the pu surface.No other damage or irregularities were noted on the returned sample.The reported issue was confirmed.The probable causes for damaged pu include damaged caused by the transfer axis in the cutter or miss handling by an operator before the dialyzer is flanged (header cap placed on dialyzer housing).A review of the production record was performed.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 user facility inventory manager reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.Additional information was obtained during follow-up with a user facility nurse.The reported issue occurred upon treatment initiation.The blood leak was noted as being an internal blood leak.The leak was visually observed within the dialyzer.The machine, a fresenius 2008k2 machine, alarmed appropriately with a blood leak alarm.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was defined as "less than 500 ml." there was no patient injury or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for 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: 24035745
• Report Number: 0001713747-2026-00026
• Device Sequence Number: 21401883
• Product Code: KDI
• UDI-Device Identifier: 00840861100163
• UDI-Public: 00840861100163
• Combination Product (Y/N): N
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/20/2026

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: 25LU04007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 03/10/2026; 03/20/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/10/2026; 03/13/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2025
• 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 2008K2 MACHINE.; FRESENIUS 2008K2 MACHINE.; FRESENIUS 2008K2 MACHINE.; FRESENIUS 2008K2 MACHINE.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 136 KG