MAUDE Adverse Event Report: KANEKA CORPORETION LIPOSORBER LA-15 SYSTEM; APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN ADULT AND PEDIATRIC PATIENTS

Model Number	LA-15
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient's fifth liposorber treatment was completed on (b)(6) 2022.The site reported no device issues or complications during treatment.The patient was hospitalized from (b)(6) 2022 due to acute kidney injury and was released when recovered.Patient also was reported to have shortness of breath and chest pain which were assessed as not related to liposorber treatment by the physician.The acute kidney injury relationship to treatment with liposorber was assessed as unknown.However, the physician has continuing the patient on liposorber treatments.
Additional Manufacturer Narrative
The device history records (dhr) of the device concerned was reviewed.The production lot, to which the device concerned belongs, passed all in-process inspections test.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.Our view; the facility has not reported any defects and malfunction in the product, and we determine that it is due to the patient's condition and usage.However, since health hazards to patients have occurred, and the causal relationship between health hazards and the product cannot be completely ruled out, we will submit mdr (30 days).

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Common Device Name: APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN ADULT AND PEDIATRIC PATIENTS
• Manufacturer (Section D): KANEKA CORPORETION; nakanoshima; kita-ku 2-3-18; osaka, 530-8 288; JA 530-8288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1 torikai-nishi; settsu-city, osaka; 56600 72; JA 5660072
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka minato-ku tokyo; JA 1071152
• MDR Report Key: 15435433
• Report Number: 3002808904-2022-00011
• Device Sequence Number: 12180939
• Product Code: PBN
• UDI-Device Identifier: 14993478010110
• UDI-Public: 14993478010110
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P910018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2022

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 Expiration Date: 11/28/2023
• Device Model Number: LA-15
• Device Catalogue Number: 101785
• Device Lot Number: LAP1585-A1603/A1604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2019
• 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: Other; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 91 KG