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 Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Hypovolemia (2243)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

The ldl-a was started immediately after completing the hd.The extracorporeal volume of the ldl-a system is larger than that of the hd system, and the patient might have developed a hypovolemia especially immediately after the hd during which the patient had already lost a certain amount of circulating blood volume.Furthermore, the patient was taking an anti-hypertensive drug and it might accelerate to cause hypotension during the ldl-a.We believe the reported event was due to the patient's intolerance to the combination procedure with the hd and the ldl-a, and not due to any defect or malfunction of the ldl-a system.If possible, combination treatment of hd and ldl-a on the same day should be avoided, and if it cannot be avoided, the ldl-a first and followed by hd may have less risk to develop a hypovolemic shock symptom.Furthermore, if possible, taking any antihypertensive drug before the ldl-a has completed should be skipped on the day of the ldl-a.

Event Description

The ldl-apheresis using the liposorber la-15 system (ldl-a) was introduced to a (b)(6) male patient on maintenance hemodialysis (hd) for the treatment of his arteriosclerosis obliterans (aso).Aso is not included in the indications of the ldl-a approved by fda in the usa.The hd was first conducted and followed by the ldl-a on the same day.Before starting the ldla, his blood pressure (bp) was over 100mmhg and was stable.The ldl-a was started at a blood flow rate (qb) of 140ml/min and a plasma withdrawal ratio (qf/qb) of 25%, by using heparin as an anticoagulant.At around 30min after starting the ldl-a, the patient alleged tiredness and the bp abruptly dropped down to 53mmhg and fell into a shock.The patient was supplemented with 100ml of saline and the ldl-a was continued at a qb of 100ml/min with a qf/qb of 25%.In 15 min, the bp returned to 130 mmhg, however the ldl-a was discontinued due to the patient's request.

• 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 530-8-288 ; JA 530-8288 ; 4613072
• MDR Report Key: 6183189
• MDR Text Key: 62639921
• Report Number: 9614654-2016-00009
• 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: 03/28/2016

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: Not provided
• 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: Initial
• 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
• Patient Age: 82 YR