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

Model Number LA-15

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Unspecified Kidney or Urinary Problem (4503)

Event Date 04/20/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 300032572
• Report Number: 3002808904-2022-00011
• Device Sequence Number: 1
• Product Code: PBN
• UDI-Device Identifier: 14993478010110
• UDI-Public: 14993478010110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 91 KG