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); Kidney injury (4882)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
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.The 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.
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.Mfr report #: 3002808904-2025-00037.
Additional Manufacturer Narrative
In addition to conditions reported in initial report # 2435151-2025-00019, we have learned patient had additional related conditions worsening ascites and acute kidney injury (aki).The patient had "ascites" prior to enrollment and it worsened during hospitalization for initially reported worsening edema.Additionally, during this hospitalization, scr 1.42 mg/dl and decreased urine output were noted, leading to a diagnosis of aki.The site classified the severity for the worsening ascites as moderate.The site classified the severity of the aki as mild.The symptoms resolved on (b)(6) 2025.The subject underwent paracentesis without issues and received an infusion of albumin x1 followed by iv lasix.After these infusions, edema resolved, ascites improved, diuresis was achieved, and aki improved.The pi has determined that this aes of worsening ascites is not an adverse device effect (ade) as the ae is related to the subjects 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; 2-3-18 nakanoshima, kita-ku; osaka, osaka 530-8 288; JA 530-8288
• MDR Report Key: 23901541
• Report Number: 2435151-2025-00019
• Device Sequence Number: 15981770
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026
• Report Date (Section F): 03/06/2026

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/05/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2025
• Supplement Report FDA Received Date: 03/06/2026
• 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: 03/06/2026