MAUDE Adverse Event Report: KANEKA CORPORATION LIPOSORBER LA-15 SYSTEM; APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN ADULT AND PEDIATRIC PATIENTS

Model Number	LA-15-AU
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Sepsis (2067); Drug Resistant Bacterial Infection (4553); Bacteremia (4846); Kidney injury (4882)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physician determined that this sae is not considered an sade (device related) since the sepsis was related to the subject's central line not the device.The subject did not develop sepsis until almost 2 weeks after the last liposorber treatment.This reporting determination is not an admission of cause or contribution, but out an abundance of caution.
Event or Problem Description
The report concerns a pediatric patient (male, 3.7 years old) with focal segmental glomerulosclerosis (fsgs) receiving ldl adsorption therapy using liposorber la-15-au.The patient underwent the 9th ldl apheresis on (b)(6) 2025.Sepsis occurred on (b)(6) 2025 due to mrsa bacteremia while hospitalized for another adverse event reported on 2435151-2026-00002.Patient was admitted to hospital on (b)(6) 2025, due to acute kidney injury (aki) with an elevated serum creatinine level of 1.38 mg/dl.Lasix started during admission.The patient received two rounds of hemodialysis, last being on (b)(6) 2025.The aki improved as mrsa bacteremia was treated with vancomycin, and the patient discharged on (b)(6) 2025.The physician determined the relation to treatment of the aki was no, because it is related to the mrsa bacteremia and the patients preexisting disease processes.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Common Device Name: APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN ADULT AND PEDIATRIC PATIENTS
• Manufacturer (Section D): KANEKA CORPORATION; 2-1, nakanoshima 2-chome, kit; osaka, osaka 530-8 288,; JA 530-8288,
• MDR Report Key: 24518459
• Report Number: 2435151-2026-00004
• Device Sequence Number: 9655665
• Product Code: PBN
• UDI-Device Identifier: 24993478010117
• UDI-Public: (01)24993478010117
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026
• Report Date (Section F): 03/05/2026

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: LA-15-AU
• Device Catalogue Number: 101788
• Device Lot Number: LAP1674
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/03/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2026
• 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: KP-05 LOT #: KP9H9R; MA-03 SERIAL #: (B)(6); NK-M3R(U) LOT#250224
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American
• Date Report Sent to FDA: 03/05/2026