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); Hypovolemia (2243); Loss of consciousness (2418)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

Since the ldl-a is necessary to take a certain amount of the blood outside the patient's body to circulate through the extracorporeal circuit, the volume of blood circulating in the patient's body decreases, and it may cause a hypovolemia.In this reported case, the ldl-a was started despite the patient's bp was already very low, and the decrease in circulating blood volume inside the patient by initiating the ldl-a was considered to cause the severe hypotension.The patient's vital conditions on the day of the event might be not tolerable to this sort of extracorporeal treatment.The ifu of the liposorber la-15 system for fsgs (distributed in usa) provides information about hypotension as an adverse event that may be associated with the use of the system.Physician's comment: although we have enough experiences of ldl-a with the liposorber la-15 system, the patient's renal function got worse rapidly and the timing to initiating ldl-a was too late.When we may resume ldl-a on this patient, make sure to initiate ldl-a after appropriately stabilizing the patient's bp.

Event Description

The ldl-apheresis with the liposorber la-15 system (ldl-a) and a hemodialysis were introduced to the patient with nephrotic syndrome due to focal glomerulosclerosis (fsgs), whose renal condition was suddenly aggravated after administrating with cyclosporine.On the day of the first ldl-a, the patient was carried into the treatment room with laying on the bed and felt tired, her blood pressure (bp) was on 80s (mmhg) measurable by a manipulation (her bp could not be measurable by a cannulation).The blood side of the extracorporeal circuit of the ldl-a was first filled with 25% albumin and the blood withdrawal was initiated with nafamostat mesilate (futhan) as an anticoagulant.After circulation only the blood for a while, the ldl-a was commenced at a blood flow of 100ml/min and a plasma separation ratio of 10%.Upon the operating nurse's repetitive calls to the patient, she replied very tired and her bp became low to 40mmhg.On continuing the ldl-a, her condition worsened and she lost consciousness with dilated pupil.Immediately, saline was infused and oxygen inhalation was started.While shaking the patient, she regained consciousness and could react to calling her name.The ldl-a was discontinued and the blood in the extracorporeal circuit was returned to the patient.

• 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 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: 6183188
• MDR Text Key: 62639913
• Report Number: 9614654-2016-00006
• 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: 02/17/2016

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: 02/17/2016
• 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: Initial
• Patient Sequence Number: 1
• Treatment: APHERESIS MACHINE KANEKA MA-03; PLASMASEPARATOR SULFLUX FP-08; TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 50