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

Model Number LA-15

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 01/07/2014

Event Type  Injury  

Event Description

The ldl-apheresis (ldl-a) with liposorber la-15 system was applied to a (b)(6) years of age female patient (hd), with diabetes mellitus (dm) and dementia, for the treatment of her arterio sclerosis obliterans (aso).In the first ldl-a of the pt, she developed a severe hypotension with a shock symptom at around 10-15 minutes after starting the procedure (at 11:07 am), and the procedure was immediately terminated.The pt fell into a temporary cardiac arrest and an automated external defibrillator (aed) was applied, saline was infused i.V., and her blood pressure (bp) gradually elevated and stayed at 70-80 mmhg (at around 12:00).Her bp recovered to 120 mmhg and she was put on a hd procedure (12:20) and completed the hd without problem (at 15:30).On the same day, her cardio thoracic ratio (ctr) was confirmed normal by an x-ray examination and she went home with no aftereffect of the incident.The pt was administered with an ace-inhibitor (lokopool: lisinopril), and the ldl-a on this day was conducted after one week-cessation of the ace-inhibitor.

Manufacturer Narrative

Anaphylactoid reactions with severe hypotension including shock are known as one of side effects, especially in patients who are concomitantly treated with ace-inhibitors, which are attributed to the dextran sulfate-cellulose gels or the ingredient of the "liposorber la-15 ldl adsorption columns".In (b)(6), patients being treated with any ace-inhibitor is contraindicated to the ldl-apheresis (ldl-a) with this device.In our investigation, the patient (pt) was prescribed with an ace-inhibitor, "lokopool", and the pt was applied to the ldl-a with this device after one week-cessation of the ace-inhibitor.The pt is on chronic hemodialysis (hd) with renal failure, and the effectiveness of the ace-inhibitor had remained longer than usual, and one week-cessation seemed insufficient to eliminate the influence of the ace-inhibitor.Her second ldl-a with this device was successfully done two weeks after this event with continuous cessation of the ace-inhibitor by using nafamostat mesilate, "futhan", as an anticoagulant.Accordingly, we believe that the event was caused by a use error to use the device against contra-indication and not be any defect or malfunction of the device.The actual device used was not available for our further investigation.

• Brand Name: LIPOSORBER LA-15 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: 3613156
• MDR Text Key: 4094505
• Report Number: 9614654-2014-00002
• 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: 01/31/2014

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 Model Number: LA-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2014
• 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: (B)(4)); PLASMA SEPARATOR, SULFLUX FP-05 ((B)(4); NK-M3R TUBING SET ((B)(4)); MA-03 APHERESIS MACHINE ((B)(4))
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 39