MAUDE Adverse Event Report: KANEKA CORPORATION LIPOSORBER LA-15 SYSTEM; LIPOPROTEIN, LOW DENSITY, REMOVAL

Model Number LA-15

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Apheresis (1719); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

Since the plasma treatment volume was 400 ml, the plasma treated by liposorber column had already returned to the patient's body.The ace inhibitor (perindopril) was withdrawn 3 days before liposorber treatment.However, perindoprilat, the active metabolite of perindopril, is a substance which remains in the blood even after 3 days of the withdrawal.In spite of not taking other antihypertensive drugs, blood pressure was maintained at 110 mmhg from the day of drug cessation.Based on these evidences, it is considered that the effect of the ace inhibitor was sustained even after the withdrawal.The implementation of liposorber treatment in patients taking ace inhibitors is alerted in ifu's contra-indications.

Event Description

A (b)(6), male, non hemodialysis patient.The first liposorber treatment on cholesterol crystal embolization.Fifteen minutes after the start of treatment which is about 400 ml of plasma treatment, blood pressure drop (from 110 mmhg to 70 mmhg) and loss of consciousness occurred.Urgent return of blood was conducted and the treatment was discontinued.The unconsciousness lasted about several seconds and the patient was recovered with 400 ml of saline supplement.Other symptoms such as feeling uncomfortable, nausea, vomiting, etc were also observed.Since ace inhibitor (perindopril) was administered 3 days before treatment, 30 mg/h of futhan (nafamostat mesilate) was used as an anticoagulant.Since bicornuate (bicarbonate ringer's solution) was used for the washing solution, futhan was not used for priming.No abnormality in the vital sign before treatment and no dehydration was observed.After withdrawal of ace inhibitor, no other antihypertensive drugs were administered.Blood pressure was maintained at 110 mmhg level even after withdrawal of ace inhibitor.The doctor suspected allergies of futhan, liposorber or sulflux (plasma separator).

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Type of Device: LIPOPROTEIN, LOW DENSITY, REMOVAL
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18, nakanoshima, kita-ku; osaka-city, 530-8 288; JA 530-8288
• Manufacturer Contact: yoshiyuki kitamura ; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka, 530-8-288 ; JA 530-8288
• MDR Report Key: 8300586
• MDR Text Key: 134858599
• Report Number: 3002808904-2018-00023
• 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: Physician
• Type of Report: Initial
• Report Date: 01/09/2019

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: 08/31/2022
• Device Model Number: LA-15
• Device Catalogue Number: N/A
• Device Lot Number: LAP1512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 88 YR