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

Model Number LA-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fever (1858)

Event Date 10/12/2017

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 261435997
• Report Number: 2435151-2021-00001
• Device Sequence Number: 1
• Product Code: PBN
• UDI-Device Identifier: 14993478010110
• UDI-Public: 14993478010110
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LA-15
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2021
• Distributor Facility Aware Date: 10/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 9 YR
• Patient Weight: 30