MAUDE Adverse Event Report: KANEKA CORP. LIPOSORBER LA-15 SYSTEM; LDL APHERESIS SYSTEM

Model Number LA-15

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

Patient Problems Apheresis (1719); Death (1802); Tachycardia (2095)

Event Date 10/18/2014

Event Type  Death  

Event Description

The ldl-apheresis with the liposorber la-15 system (ldl-a) applied to the (b)(6) female patient (pt) for the treatment of her arterio sclerosis obliterans (aso).It was her 6th ldl-a in the 2nd session (one session usually consists of 10 times of ldl-a).The pt was on chronic hemodialysis (hd), 3 times per week, on monday, wednesday and friday, and this ldl-a was conducted on saturday in the late afternoon.The ldl-a was completed without complication except for a slight tachycardia of over 100/min.(usually in around 70/min.During ldl-a) and she went home as usual.In the late afternoon of the next day, she suffered from severe dyspnea and was transferred by an ambulance to a general hospital, that is different from the site where her ldl-a has been conducted.The family member of the pt made a phone call to the physician in charge for her ldl-a and informed of her passing away.No further information is available from the patient's family.

Manufacturer Narrative

No information about the cause of the patient's death was available to the physician in charge for the patient's ldl-a, and according to us, and if the ldl-a was relevant to the patient's death could not be judged.The ldl-a on the day before the patient's death was completed without complications, and accordingly, we believe that no defect or malfunction of the devices used occurred during the ldl-a.It is well known that patients with arteriosclerosis obliterance (aso), or peripheral arterial occlusive disease (paod), have complications such as coronary and/or cerebral artery diseases, and also that chronic hemodialysis (hd) patients have higher risk for heart failure, cerebral vascular diseases and myocardial infarction.The device history record (dhr) of the la-15 with lot no.Lap1340 (speculated from the device record at the local distributor) was reviewed and no nonconformity or abnormality was found in its manufacturing processes.The device met its material, assembling and product specifications.Accordingly, we believe that the ldl-a was not relevant to the patient's death and a sudden aggravation of the underling disease(s) and or complication(s) may be responsible to the patient's death.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Type of Device: LDL APHERESIS SYSTEM
• Manufacturer (Section D): KANEKA CORP.; osaka ; JA
• Manufacturer (Section G): KANEKA CORP.
• Manufacturer Contact: masaharu inoue ; 546 fifth ave.; 21st floor; new york, NY 10036 ; 8005263522
• MDR Report Key: 4274192
• MDR Text Key: 5030414
• Report Number: 9614654-2014-00013
• Device Sequence Number: 1
• Product Code: MMY
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2014

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 Expiration Date: 06/30/2018
• Device Model Number: LA-15
• Device Lot Number: LAP1340 (SPECULATED)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2014
• Initial Date FDA Received: 11/17/2014
• 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: APHERESIS MACHINE KANEKA MA-03 (NIKKISO CO. LTD); PLASMA SEPARATOR; TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R; (NIKKISO CO. LTD); SULFLUX FP-05 (ASAHI-KASEI MEDICAL CO. LTD)
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 65