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 Problems Fever (1858); Post Operative Wound Infection (2446)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

A fsgs patient with intractable nephrotic syndrome is usually administered first with steroid to assess if the patient is steroid-resistant, and when the patient is judged steroid-resistant, ldl-apheresis will be introduced under continued administration with steroid, as so this particular patient was.Accordingly, the patient had already been susceptible to infection before and throughout the ldl-apheresis therapy.It was reported that the ldl-apheresis up to 9th procedures had completed without any problem in out-patient basis.The patient developed fever the next day of the 9th ldl-apheresis, and was in-hospitalized with increase in wbc counts and escherichia coli positive in the blood cultivation.We strongly suspect that the infection was caused through the tunneled catheter for blood access placed for over 40 days when the reported incident occurred.We believe that the contribution of the ldl-apheresis procedure itself to the infection is quite unlikely.The attending physician commented that the relationship between the ldl-apheresis and the reported event is "possibly related".Since we could not completely decline the relevance between the ldl-apheresis and the incident, we decided to make a mdr as a case which were required hospitalization.We believe this incident is attributable not to defect or malfunction of the devices but to the aggravation of the infection through the long-standing tunneled catheter.

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.

• 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, 530-8 288; JA 530-8288
• Manufacturer Contact: kazuhiko inoue ; 2-3-18,nakanoshima, kita-ku; osaka-city, osaka 530-8-288 ; JA 530-8288 ; 31814120
• MDR Report Key: 7016810
• MDR Text Key: 91806524
• Report Number: 3002808904-2017-00005
• 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: H120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Model Number: LA-15
• Device Catalogue Number: N/A
• Device Lot Number: LAP1445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• 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): Hospitalization; Life Threatening
• Patient Age: 9 YR
• Patient Weight: 30