BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPOSORBER LA-15 SYSTEM

    MDR report key: 23901541 · Received December 27, 2025

    Report

    Report Number
    2435151-2025-00019
    Event Type
    Injury
    Date Received
    December 27, 2025
    Date of Event
    November 24, 2025
    Report Date
    March 6, 2026
    Manufacturer
    KANEKA CORPORATION
    Product Code
    PBN
    UDI-DI
    24993478010117
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564611 LIPOSORBER LA-15 SYSTEM APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN ADULT AND PEDIATRIC PATIENTS PBN KANEKA CORPORATION LA-15AU 24993478010117

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male Hospitalization KP-05 LOT #: KP9H9R| MA-03 SERIAL #: (B)(6) | NK-M3R(U) LOT#250224