MAUDE Adverse Event Report: KANEKA CORPORATION LIPOSORBER LA-15 SYSTEM

Model Number	LA-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Loss of consciousness (2418)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Nurse emailed reporting patient's treatment had to be d/c d/t pt reporting abd pain (6/10 on pain scale).Pt stated she had her last day of menses the day before treatment.Just before the event occurred, the patient's vitals were: bp 111/58, hr 95, spo2 99% on room air.With 50 minutes remaining of treatment, the patient began writhing in severe abdominal pain that caused the patient to pass out.Treated plasma volume at the event: 2400 ml.Nurse terminated treatment and patient was transferred to emergency room.Per nurse, the patient experienced relief after 1 hour off the treatment and was discharged home.The patient did not receive any pain medication and ct scans of the abdomen were negative.Nurse stated this patient has been receiving treatment for over a year and has successfully completed treatments without any complications.The treating physicians have decided to hold off treatment until it can be determined what the root cause of the abdominal pain is.The treating nurse stated, she does not believe it is the liposorber and the physicians are continuing to run test for patient to determine cause of abdominal pain.The kaneka 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: LA-15
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18 nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• MDR Report Key: 21699282
• Report Number: 2435151-2025-00004
• Device Sequence Number: 15660827
• Product Code: MMY
• UDI-Device Identifier: 14993478010110
• UDI-Public: (01)14993478010110(17)271228(10)LAP1664
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/26/2025
• Report Date (Section F): 02/26/2025

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-15
• Device Catalogue Number: 101785
• Device Lot Number: LAP1664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2025
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2025
• 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: (B)(4); (B)(4); (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 18 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/26/2025