MAUDE Adverse Event Report: KANEKA CORPORATION OSAKA PLANT LIXELLE (MODEL: S-25); BETA 2-MICROGLOBULIN APHERESIS COLUMN

Model Number	S-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Fatigue (1849)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient, an 81-year-old female with a history of long-term hemodialysis, started treatment with lixelle s-25 on (b)(6) 2025 for dialysis-related amyloidosis.On (b)(6) 2025, hemoglobin decreased to 6.7 g/dl (previous value in july: 13.8 g/dl without esa).The patient was hospitalized from (b)(6) 2025 primarily for blood transfusion therapy and monitoring.Rbc transfusions were administered (2 units on 08-29 and 2 units on 08-30), and darbepoetin (10 mcg weekly) was initiated.Considering the patient's preference, further application of lixelle in subsequent dialysis sessions was discontinued.Hemoglobin improved to 10.7 g/dl by (b)(6) 2025.The physician indicated a possible relationship between the device and the event; relationships with other devices or drugs were not confirmed.Mfr report #: 3002808904-2025-00033.

• Brand Name: LIXELLE (MODEL: S-25)
• Common Device Name: BETA 2-MICROGLOBULIN APHERESIS COLUMN
• Manufacturer (Section D): KANEKA CORPORATION OSAKA PLANT; 5-1-1, torikai-nishi; settsu-shi,, osaka 566-0 072,; JA 566-0072,
• MDR Report Key: 23324328
• Report Number: 2435151-2025-00012
• Device Sequence Number: 9909874
• Product Code: PDI
• UDI-Device Identifier: 14993478020225
• UDI-Public: 14993478020225
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2025
• Report Date (Section F): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: S-25
• Device Lot Number: BMP1932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/03/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DARBEPOETIN ALFA.; KINDALY 5E (DIALYSATE).; RBC TRANSFUSION (2 UNITS).; RBC TRANSFUSION (2 UNITS).
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian
• Date Report Sent to FDA: 10/17/2025