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

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

Patient Problems Death (1802); Sudden Cardiac Death (2510)

Event Date 12/04/2015

Event Type  Death  

Manufacturer Narrative

On the previous day of the event ldl-apheresis with the concerned device was completed without any complication.Next day, the patient completed hemodialysis and spent hours in his patient's room normally before the event occurred.Then, the patient suddenly lost consciousness and entered into cardiopulmonary arrest.Therefore, it is speculated that sudden death occurred after some catastrophic events.No information about the cause of death of the patient was provided.On fsgs, the causes of death in general are reported as follows: malignant tumors for 1.4%, infectious disease for 0.7%, abdominal aortic aneurysm-rupture for 0.4%, heart failure for 0.4%, and sudden death for 0.4%.(the japanese journal of nephrology, vol.44, pp 751-761, 2002.) although the physician in charge commented that ldl-apheresis could not be relevant to the patient's death, we cannot completely exclude a possibility that ldl-apheresis and/or hemodialysis is relevant to the catastrophic events occurred.

Event Description

A maintenance hemodialysis patient with new-onset of focal glomerulosclerosis (fsgs).No other complications were observed.As steroid was not effective on fsgs, ldl-apheresis therapy using the liposorber a-15 system was commenced.On (b)(6) his 8th ldl-apheresis was conducted.On (b)(6) he underwent hemodialysis without any complication, returned to his patient's room and took a meal.He had a conversation normally, although he confessed slightly ill.Then, he suddenly lost consciousness at 15:30, and suffered cardiopulmonary arrest.He recovered once after resuscitation, but died at 16:07.

• 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 530-8-288 ; JA 530-8288 ; 4613072
• MDR Report Key: 6183187
• MDR Text Key: 62669501
• Report Number: 9614654-2016-00001
• 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: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: APHERESIS MACHINE KANEKA MA-03; SULFLUX PLASMA SEPARATOR; TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 47