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

Model Number LA-15

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914)

Event Date 04/21/2017

Event Type  Injury  

Manufacturer Narrative

The actual la-15 ldl adsorption columns used was returned and investigated.No abnormality by visual examinations was observed.The manufacturing records (dhr) of the device based on the lot and serial numbers of the devices concerned was reviewed and no nonconformities was observed.After confirming that some portions of the hollow fibers of the sulfux fp-08 plasmaseparator were colored in purple, and the plasmaseparator was sent to the manufacturer, asahi-kasei medical, for their investigations.The physician in charge commented that the plasmaseparator might have been attributable to the reported patient's reactions.However, we cannot completely exclude a possibly that the ldl-a procedure is relevant to the acute hypotension occurred since the extracorporeal volume in the ldl-a is larger than that of a hemodialysis procedure.

Event Description

The patient was on a maintenance hemodialysis and complicated with peripheral artery disease (pad) and diabetes, who had completed one set of ldl-apheresis (ldl-a) sessions using liposorber la-15 system for the treatment of pad before without problem.It was the first ldl-a procedure of the second set of ldl-a sessions, and the patient went into anaphylactic shock accompanied by hypotension down to 70-80mmhg (normally 120-130mmhg) 30 minutes after start of the ldl-a, or at 500ml of treated plasma volume.Some parts of the hollow fibers of the plasmaseparator, sulflux fp-08, appeared colored in purple instead of usual white in the completion of plasma/blood return procedure after the treatment.The patient was administered with a supplementation fluid and steroid when entered into the shock, and the symptom subsided.Heparin was used for an anticoagulant during the ldl-a.The patient was administered with an antidiarrhoic, loperamide, and did not take any angiotensin converting enzyme (ace) inhibitor.After the events during ldl-apheresis, the patient keeps receiving maintenance hemodialysis as usual.

• 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: kazuhiko inoue ; 2-3-18,nakanoshima, kita-ku; osaka-city, 530-8-288 ; JA 530-8288 ; 4613072
• MDR Report Key: 6649382
• MDR Text Key: 77822651
• Report Number: 9614654-2017-00006
• 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: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: LA-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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): Life Threatening