MAUDE Adverse Event Report: KANEKA CORPORATION LIPOSORBER LA015 SYSTEM; LDL APHERESIS SYSTEM

Model Number LA-15

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Disseminated Intravascular Coagulation (DIC) (1813); Edema (1820); Embolism (1829); Hemorrhage/Bleeding (1888); Hemorrhage, Intraventricular (1892); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045); Loss of consciousness (2418)

Event Date 02/24/2014

Event Type  Death  

Event Description

Te ldl-apheresis (ldl-a) with liposorber la-15 system was applied to the patient (pt) for the treatment of his arterio sclerosis obliterans (aso).He has developed cholesterol crystal embolization (cce) after receiving a percutaneous coronary intervention (pci).He rec'd the first ldl-a on (b)(6) (10 days ago), and it was his second treatment with the ldl-a.He also developed disseminated intravascular coagulation syndrome (dic) developed, and a gastrointestinal bleeding was observed on the day of the ldl-a.On the day of the event, he rec'd first a continuous hemodiafiltration (chdf) followed by the ldl-a in icu.At the start of the ldl-a procedure, he had already a difficulty to breath normally with mandibular-breathing, edema of the whole body, lower level of consciousness, and the blood pressure (bp) was 90mmhg.His bp further dropped during the ldl-a, and he developed a very severe hypotension to become unconscious, and cardiopulmonary arrest at around one (1) hour after starting the procedure.The ldl-a was immediately terminated, cardiac compression was performed, adrenalin was given by intracardiac injection, and cardiac compression was continued, but the patient died.The time course of the ldl-a on that day was as follows: 11:15 (am), the ldl-a was initiated with the operating conditions of the blood flow rate (qb) with 70ml/min and a plasma filtration ratio (qf) of 20% (14ml/min).The patient's bp was 90mmhg, 11:40, his bp dropped to 60mmhg from 70mmhg and qb was reduced to 60ml/min., at around 500ml of processing plasma volume, 11:50, no sign of his bp's going up was seen, 12:00, qb was further reduced to 50ml/min., at around 800ml of processing plasma volume, 12:10, his bp dropped to 30-40mmhg and the operating nurse called the doctor for the termination of the treatment.At 12:15, the nurse stopped the pumps of the apheresis machine and intended to return the blood and the plasma to the patient; however, the patient's condition suddenly deteriorated to become unconscious with cardiac arrest and performed cardiac compression.Adrenaline was given by intracardiac injection and cardiac compression was continued; however, patient died.

Manufacturer Narrative

According to the physician in charge, the patient had developed dic, gastrointestinal bleeding necessitated with blood transfusion, and his physical status was very poor with mandibular breathing, lower bp with lower consciousness level when the ldl-a was started after a chdf.The physician in charge commented that the patient's death was not attributable to the ldl-a itself taking into account the circumstances of the patient's physical conditions although it could not completely be excluded since the hypotension resulted finally in the patient's death occurred during the ldl-a procedure.We believe that the patient's physical condition on the day of the event was too poor and intolerable to the ldl-a procedure, and accordingly, the patient's death is attributable neither to the device failure nor the ldl-a itself with the device.

• Brand Name: LIPOSORBER LA015 SYSTEM
• Type of Device: LDL APHERESIS SYSTEM
• Manufacturer (Section D): KANEKA CORPORATION; osaka ; JA
• Manufacturer (Section G): KANEKA CORPORATION; 2-3-18 nakanoshima, kita-ku; osaka 530- 8288; JA 530-8288
• Manufacturer Contact: masaharu inoue ; 546 fifth avenue 21st floor; new york, NY 10036 ; 8005263522
• MDR Report Key: 3678702
• MDR Text Key: 4299983
• Report Number: 9614654-2014-00004
• Device Sequence Number: 1
• Product Code: MMY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• 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
• 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: Initial
• Patient Sequence Number: 1
• Treatment: MA-03 APHERESIS MACHINE (NIKKISO CO., LTD); PLASMA SEPARATOR; NK-M3R TUBING SET (NIKKISO CO., LTD); SULFUX FP-08 (ASAHI-KASEI MEDICAL CO., LTD)
• Patient Outcome(s): Death
• Patient Age: 86 YR