MAUDE Adverse Event Report: KANEKA MEDICAL AMERICA LIPOSORBER LA-15 SYSTEM; LIPOPROTEIN, LOW DENSITY, REMOVAL

Model Number	LA-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During temporary withdrawal from la-15 treatment for toilet the blood pressure was further reduced and the consciousness was lost due to a decrease in blood circulation in the body, and due to a rise in blood bradykinin caused by gradual increase in plasma flow during the course of treatment.There was a slight decrease in blood pressure, nausea, and a feeling of fainting in the first treatment, however the treatment could have finished until the target plasma treatment volume.The loss of consciousness occurred in the second treatment also possibly due to the bad patient's physical condition on the day of the second treatment.
Event or Problem Description
The case is a patient with familial hypercholesterolemia and hyper-lp (a)emia.During the second la-15 treatment the patient temporarily broke away from la-15 treatment due to toilet, and the blood pressure decreased (98 / 56mmhg) and the patient lost consciousness.The blood pressure recovered to 124/68 and thereafter la-15 treatment was resumed.La-15 treatment was discontinued at a plasma treatment volume of 3.8 l although the target volume was set to 4.45l.The first la-15 treatment was conducted two weeks before the second treatment.Although mild decrease in the blood pressure to 90's, feeling of faint and nausea during the treatment were observed.The target plasma treatment volume 4.4l was accomplished.Concomitant medications: lisinopril (ace-inhibitor) was withdrew 6 days before the first la-15 treatment.Plavix (antiplatelet drug) zetia (cholesterol lowering drug) mfr# 3002808904-2020-00005.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Common Device Name: LIPOPROTEIN, LOW DENSITY, REMOVAL
• Manufacturer (Section D): KANEKA MEDICAL AMERICA; 623 fifth avenue; new york NY 10022
• MDR Report Key: 11036530
• Report Number: 2435151-2020-00001
• Device Sequence Number: 1194128
• Product Code: MMY
• UDI-Device Identifier: 14993478010110
• UDI-Public: 14993478010110
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/18/2020
• Report Date (Section F): 02/20/2020

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 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: 02/17/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/20/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Weight: 86