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

Model Number LA-15

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

Patient Problem Dyspnea (1816)

Event Date 10/19/2016

Event Type  Death  

Manufacturer Narrative

The doctor in charge said that the cause of her death was myocardial infarction and was not attributable to the ldl-a.As the physician stated she died of myocardial infarction.However, her later development of myocardial infarction might have been relevant to a sudden change in her physical condition during the ldl-a such as dyspnea.Futhan shock, bradykinin related anaphylactoid reaction, etc.Might be possible causes of the sudden change in her physical condition during the ldl-a.The antibody test to futhan on the day before the event was negative, whereas the result of the allergic test to futhan of the patient was not available.The bradykinin related anaphylactoid reaction can be denied because of the use of futhan as an anticoagulant during the ldl-a on the event.Futhan is known to suppress bradykinin generation during the ldl-a.Although the physician in charge commented that the ldl-a was not relevant to the patient's death, a possibility that the ldl-a was relevant to the catastrophic events occurred during the ldl-a cannot, we consider, be completely excluded.

Event Description

The subject is a hemodialysis patient complicated with arteriosclerosis obliterans (aso).She has a history of diabetes and was put on a pacemaker.She was treated by ldl-apheresis (ldl-a) using liposorber la-15 system for the treatment of aso.It was her 6th ldl-a treatment of the 3rd course of ldl-a when the event occurred.Usually one course of ldl-a on aso consists of 10 treatments.Her physical condition changed suddenly and she caused dyspnea at about 50min after starting ldl-a.The extracorporeal blood was returned to her immediately.Since even after bronchial intubation and oxygen inhalation she did not recover, she was transferred to the general hospital which this dialysis center was an affiliate of.The values of oxygen saturation were 98% at the start of ldl-a and 70% at the onset of event.Her systolic blood pressure was 90mmhg usually before ldl-a and was 120mmhg at the onset of the event.Futhan (or nafamostat mesilate), a protease inhibitor, was used as the anticoagulant of ldl-a since the 3rd ldl-a converting from heparin, because she developed a feeling of breathing difficulty during ldl-a under heparin, which might have caused by increase in bradykinin generation.The result of the antibody test on futhan was negative on the day before the event.Ldl-a conditions on the day of the event: the blood flow rate (qb) was 100ml/.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Type of Device: LIPOPROTEIN, LOW DENSITY, REMOVAL
• Manufacturer (Section D): KANEKA CORP.; 2-3-18,nakanoshima,kita-ku; osaka 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 ; 4613072
• MDR Report Key: 6183191
• MDR Text Key: 62678646
• Report Number: 9614654-2016-00022
• Device Sequence Number: 1
• Product Code: MMY
• UDI-Device Identifier: 14993478010110
• UDI-Public: 14993478010110
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P910018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2016

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
• Device Operator: Health Professional
• Device Model Number: LA-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 50