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 Codes	Dyspnea (1816); Ascites (2596); Abdominal Distention (2601); Swelling/ Edema (4577)
Date of Event	11/24/2025
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 7th liposorber treatment on (b)(6) 2025.Approximately 3-4 days after the treatment, the patient developed a ~5-pound weight gain with worsening edema and dyspnea.On (b)(6) 2025, the patient was hospitalized due to worsening edema and shortness of breath.Medical interventions included albumin infusion, iv furosemide (lasix), and paracentesis.The patient improved with treatment and was discharged on (b)(6) 2025.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 unknown, and the treating physician noted that the sae was considered related to the patient's underlying condition rather than the device.
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-a0366 / lap1674-a0367, 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 unknown; while the event was considered related to the patient's underlying condition, device contribution cannot be completely excluded based on the limited information available.

• 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
• Manufacturer (Section G): KANEKA CORPORATION (OSAKA PLANT); 2-chome, torikai-nishi; settsu-shi, osaka 566-0 072; JA 566-0072
• Manufacturer Contact: akihiro tahara ; 1-12-32 akasaka, ark mori building,; minato-ku,; tokyo 107-6-028 ; JA 107-6028
• MDR Report Key: 23894254
• Report Number: 3002808904-2025-00037
• Device Sequence Number: 4539200
• Product Code: PBN
• UDI-Device Identifier: 24993478010117
• UDI-Public: (01)24993478010117(17)280728(10)LAP1674
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2025

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: LA-15AU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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: KP-05 LOT #: KP9H9R; MA-03 SERIAL #: J1910217; 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