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

Model Number	LA-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dehydration (1807); Unspecified Kidney or Urinary Problem (4503); Swelling/ Edema (4577)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
On (b)(6) 2020, patient received treatment with liposorberla-15 system.The treatment was completed.At 4:00pm the patient was admitted to the hospital for anasarca with worsening aki exacerbated by dehydration in the setting of elevated cyclosporine levels.The site noted that the sae is possibly related to the treatment and that the device did not malfunction.On 11/23/2020, the site reported the sae, classified the adverse event as serious, and noted that the patient was still hospitalized.On 11/30/2020 user facility reported la-15 system lot and serial numbers.They reported that the adverse event has ended on (b)(6) 2020 and that the patient would be continuing treatment with the liposorber system.User facility reported actions taken to treat adverse event as the following medications; cyclosporine held, fluconazole held, lasix oral and iv, and 25% albumin.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Common Device Name: APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN ADULT AND PEDIATRIC PATIENTS
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima; kita-ku, osaka 23082 88; JA 2308288
• MDR Report Key: 11044208
• Report Number: 3002808904-2020-00021
• Device Sequence Number: 16415819
• Product Code: PBN
• UDI-Device Identifier: 14993478010110
• UDI-Public: 14993478010110
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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: 09/28/2023
• Device Model Number: LA-15
• Device Catalogue Number: 101785
• Device Lot Number: LAP1547-A0870,A0871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/21/2020
• 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
• Patient Age: 16 YR
• Patient Weight: 67