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

Model Number	LA-15AU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
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 8th liposorber treatment on (b)(6) 2025.During the treatment, the patient developed increased work of breathing (dyspnea) and was immediately admitted to the hospital.At the time of reporting, the patient remained hospitalized and the final outcome was not yet available; the site planned to provide an update when the outcome becomes known.The event was assessed as a serious adverse event (sae) requiring hospitalization; it was not classified as a serious adverse device effect (sade).The relationship to the device was recorded as not related.Mfr report #: 3002808904-2025-00036.
Additional Manufacturer Narrative
Manufacturer evaluation: the suspect device was not available for evaluation because it was reportedly discarded by the user facility and not returned.Therefore, device and component-level evaluation could not be performed.A review of device history records (dhr) for liposorber la-15-au, lot no.Lap1674- a0626/a0627 or a0636/a0637, was conducted.No nonconformities or abnormalities were identified during the manufacturing process.Based on the currently available information, no device malfunction was reported.The event was assessed as a serious adverse event requiring hospitalization and was not classified as a serious adverse device effect (sade).The relationship to the device was recorded as not related while the event was considered related to the patient's underlying condition, device contribution cannot be completely excluded based on the limited information available.Based on the manufacturing records, the combination "lap1674-a0626/a0637" is not possible.We believe this is a documentation error and that the correct lot combination is either "a0626/a0627" or "a0636/a0637." accordingly, we have reviewed the dhr for both possible combinationsthe device has not been determined to have caused or contributed to the adverse event.This incident is being reported out of an abundance of caution.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Common Device Name: APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN ADULT AND PEDIATRIC PATIENTS
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18 nakanoshima, kita-ku; osaka, osaka 530-8 288,; JA 530-8288,
• MDR Report Key: 23988942
• Report Number: 2435151-2026-00001
• Device Sequence Number: 17281635
• Product Code: PBN
• UDI-Device Identifier: 24993478010117
• UDI-Public: (01)24993478010117(17)280728(10)LAP1674
• 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): 01/07/2026
• Report Date (Section F): 01/07/2026

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-15AU
• 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: 12/08/2026
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2026
• 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
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American
• Date Report Sent to FDA: 01/07/2026