MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT DIALYZER; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	UNKNOWN- DIALYZER
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility's dialysis manager reported that a 2008t hemodialysis (hd) machine had blood in it due to a dialyzer blood leak during a patient¿s hemodialysis (hd) treatment.A fme field service technician (fst) was called onsite and bleached the machine and replaced the balance chamber assembly, flow pump head and various tubing.Machine functional tests were completed and passed onsite after repair.Upon follow up, the dialysis manager said that the dialyzer leak was a visible internal dialyzer blood leak that occurred thirty minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The machine alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.A fme bloodline was in use.There was no obvious defect or damage seen on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 30ml.The patient was restarted on a new machine and treatment completed successfully with new supplies.There was no patient injury or medical intervention required due to the reported event.The complaint device is not available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As no lot number was provided for this complaint, a search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.Seven lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on one of the lots which was 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 lots 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.

• Brand Name: DIALYZER
• 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 ; +1(617)417-5172
• MDR Report Key: 50501075
• Report Number: 0001713747-2026-00327
• Device Sequence Number: 21393527
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: UNKNOWN- DIALYZER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/23/2026
• 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: FME Bloodlines.; FME Hemodialysis Machine.
• Patient Sex: Unknown