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 Problem Shock (2072)

Event Date 12/10/2013

Event Type  Injury  

Event Description

The ldl-apheresis (ldl-a) with liposorber la-15 system was applied to the pt (pt) on chronic hemodialysis (hd) for the treatment of arterio sclerosis obliterance (aso).In the first ldl-a, the pt developed a shock symptom at the very beginning of the procedure and the procedure was immediately terminated.They found that the pt was prescribed with an ace-inhibitor (enalato:enalapril maleate).The second ldl-a was conducted by one-week cessation of the ace-inhibitor, however, the pt developed again a similar shock symptom.

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 contra-indicated to the ldl-apheresis with this device.In our investigation, the pt was found taking an ace-inhibitor, "enalato", and the apheresis unit conducted the ldl-apheresis with this device without being aware of the fact that the pt was taking the ace-inhibitor.Accordingly, we believe that the event was caused by a user 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.The pt is on chronic hemodialysis (hd) with renal failure, and the effectiveness of the ace-inhibitor had remained longer than usual at the second event after one week cessation of the ace-inhibitor.Currently no more ldl-apheresis procedure with this device is schedule n this pt.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Type of Device: LDL APHERESIS SYSTEM
• Manufacturer (Section D): KANEKA CORP.; osaka ; JA
• Manufacturer (Section G): KANEKA CORP.; 2-18-3 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: 3571229
• MDR Text Key: 4213575
• Report Number: 9614654-2014-00001
• 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: 01/07/2014

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: 01/13/2014
• 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: MA-03 APHERESIS MACHINE (NIKKISO CO., LTD.); SULFLUX FP-05 (ASAHI-KASEI MEDICAL CO., LTD); PLASMA SEPARATOR; NK-MR3 TUBING SET (NIKKISO CO., LTD.)
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 46