MAUDE Adverse Event Report: KANEKA CORPORATION LIXELLE S-15; BETA2-MICROGLOBULIN APHERESIS COLUMN,

Model Number	S-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Loss of consciousness (2418)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event occurred during a blood purification therapy using lixelle s-15.Approximately 50 minutes after the start of dialysis, the patient complained of feeling unwell, followed by loss of consciousness and a significant drop in blood pressure.Cardiopulmonary resuscitation, including chest compressions, was performed, and the patient regained consciousness.The treatment session was aborted.Subsequent sessions were performed using online hdf without lixelle, and no further issues were reported.The suspect device was not returned; therefore, no physical evaluation could be conducted.Based on information obtained from the user facility and review of the device labeling, no evidence of device malfunction was identified.The root cause could not be determined; however, the likelihood of a device-related cause appears low at this time.Investigation codes: b17 (device not returned), c20 (no findings available), d14 (no problem detected).
Event or Problem Description
The patient had been receiving lixelle s-15 therapy since (b)(6) 2025 for improvement of dialysis-related amyloidosis symptoms.Treatment was paused for one month in august and restarted in early (b)(6).On (b)(6) 2025, approximately 50 minutes after resuming dialysis with lixelle, the patient complained of palpitations and feeling unwell, followed by sudden loss of consciousness and vomiting.Blood pressure dropped from 160 mmhg to 100 mmhg.Emergency intervention was performed, including immediate cessation of treatment and chest compressions, which successfully restored consciousness.No hospitalization was required.On (b)(6) 2025, dialysis was performed without lixelle and was uneventful.The patient has remained stable on i-hdf therapy since then.The event was **considered life-threatening** and required intervention to prevent permanent impairment.Mfr report #: 3002808904-2025-00034.

• Brand Name: LIXELLE S-15
• Common Device Name: BETA2-MICROGLOBULIN APHERESIS COLUMN,
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18 nakanoshima, kita-ku; osaka, osaka 530-8 288; JA 530-8288
• MDR Report Key: 23324356
• Report Number: 2435151-2025-00014
• Device Sequence Number: 16105138
• 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-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/10/2025
• 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: HEMODIALYSIS (WITH LIXELLE S-15).; ONLINE HEMODIAFILTRATION (I-HDF).
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian
• Date Report Sent to FDA: 10/17/2025