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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
In this case, a 3.7-year-old male fsgs-pas subject (b)(6) experienced worsening edema on the day after the last treatment with liposorber la-15-au (last treatment: on (b)(6) 2025; event detected: on (b)(6) 2025, 09:55).The event was assessed as moderate and required hospitalization with albumin administration, lasix, and one hemodialysis session.No device malfunction was reported, and the device was disposed of by the hospital and not returned.The site principal investigator assessed the event as not sade (not device-related); the rationale is currently under inquiry.The manufacturer conducted a dhr review (december 25, 2025) and found no nonconformities or abnormalities.This report is submitted as a precaution under 21 cfr 803 and does not constitute an admission of causality.Mfr#: 3002808904-2025-00038.
Additional Manufacturer Narrative
Initial report: manufacturer evaluation is ongoing.Event summary (based on information provided by the user facility): the patient experienced worsening edema following use of the suspect device.The patient was hospitalized and received albumin and diuretic (lasix); one session of hemodialysis was performed.Device availability / evaluation: the suspect device was discarded by the user facility and was not returned to the manufacturer; therefore, no empirical testing or physical evaluation of the actual device could be performed.Investigation performed to date: the manufacturer reviewed production records (dhr review) for the suspected lot(s); no anomalies, nonconformities, or manufacturing deviations were identified.In addition, the information provided by the user facility did not describe any specific device malfunction or performance issue during use.Trend analysis has not been performed at this time.Because the actual device was not available for evaluation, investigation findings and a definitive root cause conclusion are pending completion.Follow-up: a supplemental/follow-up report will be submitted if additional relevant information becomes 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.Note: product code pbn, esubmitter error was not finding any product codes and would not allow code typed in to be saved.Software would not allow packaging of submission due to error.Contacted (b)(6) and on (b)(6) 2026, they pushed new build that fixed issue.
Additional Manufacturer Narrative
The last treatment on (b)(6) 2025 lasted 2.25 hrs, plasma volume treated 2000ml, (qb) blood flow rate max 55 ml/min and (qf) filtration flow rate max 16 ml/min.During the previously reported worsening edema, the patient had ascites that were present prior to enrollment and it worsened during hospitalization.The subject underwent paracentesis without issues and was given an infusion of albumin and lasix, and the condition improved.The pi has determined that the worsening ascites is not an adverse device effect and that it is related to the subjects preexisting disease processes.Date symptoms disappeared on (b)(6) 2025.

• 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: 24144113
• Report Number: 2435151-2026-00002
• Device Sequence Number: 8887249
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026
• Report Date (Section F): 02/12/2026

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: 10788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/18/2025
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2026
• 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: 01/22/2026
• Supplement Report FDA Received Date: 02/13/2026
• 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: 02/12/2026