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 Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Presyncope (4410)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 device evaluation status: not returned / facility disposal.Device was not returned for evaluation.Facility disposed of the device per standard protocol.Investigation was limited to internal record review.H7 remedial action detail: facility re-education on ace inhibitor contraindication as a remedial action, the importer provided re-education to the healthcare facility regarding the critical importance of verifying that patients are not on ace inhibitors prior to liposorber apheresis treatment.The training emphasized that ace inhibitors are contraindicated due to interaction with dextran sulfate in the columns, which can trigger bradykinin-mediated effects.The importer recommended that discontinuation or substitution of ace inhibitors with an alternative class of antihypertensive medication be performed at the physician's discretion.Additionally, it was recommended to conduct patient education separately and to verify medication status before each treatment.The healthcare facility was also advised to contact the hotline for any questions or concerns related to treatment, especially for similar cases.
Event or Problem Description
The patient had not received treatment for approximately 1.5 years, and the current session marked the resumption of therapy after a prolonged interruption.Approximately 15 minutes into the treatment, the patient developed nausea, vomiting, hypotension, and tachycardia.The procedure was halted, and the blood was returned to the patient.After symptomatic improvement, a second treatment was initiated.However, immediately following re-initiation, the patient experienced chest pain, cold sweats, and perioral numbness, prompting emergency transportation to a medical facility.Subsequent evaluation revealed that the patient had been taking an ace inhibitor, which may have contributed to the adverse reaction.The attending physician instructed temporary discontinuation of the ace inhibitor and scheduled re-treatment 72 hours later, contingent upon stabilization.The patient recovered, and the healthcare provider later reported to the distributor that the patient was in "good condition.".

• 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: 23493592
• Report Number: 3002808904-2025-00035
• Device Sequence Number: 9037852
• Product Code: PBN
• UDI-Device Identifier: 24993478010117
• UDI-Public: (01)24993478010117(17)280728(10)LAP1674
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: HDE H170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring,Other,Notification
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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-15 (AU)
• Device Lot Number: LAP1674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• 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: LISINOPRIL
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 83 KG