MAUDE Adverse Event Report: KANEKA CORPORETION LIPOSORBER; LA-15

Model Number	LA-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Renal Failure (2041); Renal Impairment (4499)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Symptoms: on (b)(6) 2025.Serum creatinine level increased sharply from 1.8 to 3.5, leading to hospitalization for acute kidney injury (aki).A renal biopsy performed on (b)(6) confirmed the following diagnoses: chronic active t-cell mediated rejection active antibody-mediated rejection the patient was discharged on (b)(6).Device issues during treatment: no issues reported.The device was disposed of after treatment and was not returned.No direct malfunction or abnormality of the product was reported."based on the physician's clinical assessment, it was determined that the device did not cause or contribute to the reported serious injury.".
Additional Manufacturer Narrative
The case involved hospitalization and a renal biopsy procedure, and was therefore classified as a serious adverse event (sae).Based on the who-umc causality assessment system, the relationship was judged as "unlikely".Considering available information and reasonable inference, the causal relationship is considered weak, with low direct association, though it cannot be completely ruled out.

• Brand Name: LIPOSORBER
• Common Device Name: LA-15
• Manufacturer (Section D): KANEKA CORPORETION; kita-ku,nakanoshima; osaka, osaka 53085 28; JA 5308528
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1 torikai-nishi; settsu, osaka 56600 72; JA 5660072
• Manufacturer Contact: akihiro tahara ; minato-ku1-12-32; akasaka,; tokyo 10760-28 ; JA 1076028
• MDR Report Key: 22260600
• Report Number: 3002808904-2025-00021
• Device Sequence Number: 7644703
• Product Code: PBN
• UDI-Device Identifier: 24993478010117
• UDI-Public: (01)24993478010117(17)260128(10)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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 Lot Number: LAP1619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Other
• Patient Age: 15 YR
• Patient Sex: Male