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

Model Number	LA-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fever (1858)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A pediatric patient developed focal segmental glomerular sclerosis (fsgs) with steroid resistant nephrotic syndrome.A tunneled.Catheter for blood withdrawing was placed at right internal jugular vein on (b)(6) 2017 for commencing ldl-apheresis using.The liposorber la-15 system.The ldl-apheresis up to 9th on (b)(6) was conducted without any problem in out-patient basis.Since the patient had fever on the next day of 9th ldl-apheresis, she was admitted to the hospital for further examination and medication.Her wbc was 34200/microliter and the result of the blood culture was escherichia coli positive, which was found to become negative after administration of antibiotics.The 12th ldl-apheresis, the final session, on (b)(6) was over without any problem.The attending physician was planning to discharge the patient after removing the catheter.Mfr report #: 3002808904-2017-00005.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Common Device Name: APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN PEDIATRIC PATIENTS
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18, nakanoshima, kita-ku,; osaka-city, osaka 530-8 288; JA 530-8288
• MDR Report Key: 11635097
• Report Number: 2435151-2021-00001
• Device Sequence Number: 3684085
• Product Code: PBN
• UDI-Device Identifier: 14993478010110
• UDI-Public: 14993478010110
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2021
• Report Date (Section F): 04/07/2021

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: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 9 YR
• Patient Weight: 30
• Date Report Sent to FDA: 04/07/2021