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 Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914); Anaphylactoid (2218)

Event Date 09/08/2016

Event Type  Injury  

Manufacturer Narrative

Anaphylactoid reactions with severe hypotension including shock during the ldl-a procedure with liposorber la-15 system are known as one of severe side effects, especially in patients who are concomitantly medicated with ace-inhibitors, which are attributed to the dextran sulfate-cellulose gels (or the ingredient of the "liposorber la-15 ldl adsorption columns").In japan, patients being treated with any ace-inhibitor is contra-indicated to the ldl-a procedures with this device.It was revealed that the patient had been prescribed with an ace-inhibitor in other hospital, and the physicians conducted the ldl-a on this patient without aware of the fact that the patient was under the influence of an ace-inhibitor.Accordingly, we believe that the event was caused by a use error to apply the device against its contra-indication, and not by any defect or malfunction of the device.The actual device used was not available for our further investigation.

Event Description

This incident occurred in (b)(6).The ldl-apheresis (ldl-a) with liposorber la-15 system was applied to a hypercholesterolemic patient with arterio- sclerosis obliterans (aso).The patient developed a shock symptom with a severe hypotension at around 15 minutes after starting the ldl-apheresis.The ldl-a procedure was immediately terminated and the patient's blood pressure was stabilized by administering adrenaline.It was revealed later that the patient had been prescribed in other hospital with ace-inhibitor, that is contra-indicated to this ldla procedure in (b)(6).

• 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-city 530-8 288; JA 530-8288
• Manufacturer Contact: kazuhiko inoue ; 2-3-18 nakanoshima, kita-ku; osaka-city, osaka ; JA ; 4613072
• MDR Report Key: 6183190
• MDR Text Key: 62678481
• Report Number: 9614654-2016-00020
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2016
• 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; PLASMASEPARATOR SULFLUX FP-05; TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R
• Patient Outcome(s): Life Threatening