MAUDE Adverse Event Report: KANEKA CORP. LIPOSORBER LA-15 SYSTEM; LDL APHERSIS SYSTEM

Model Number LA-15

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 01/30/2014

Event Type  Injury  

Event Description

The ldl-apheresis (ldl-a) with liposorber la-15 system was applied to a (b)(6) years of age female in-patient (pt) for the treatment of her arterio sclerosis obliterance (aso).The patient is not on chronic hemodialysis (non-hd), non-diabetic, amputated at below the knee (the right leg) and scleroderma.It was her very first experience with the ldl-a.She developed a very severe hypotension to become unconscious, cardiopulmonary arrest at around one (1) hour after starting the procedure.The procedure was immediately terminated, and cardiac massage, bosmin (adrenalin) i.V.Administration, was given to her.Her blood pressure gradually rose and she revived approximately ten (10) minutes after.However, her blood pressure dropped and her conscious level lowered again at around 20 minutes after the revival.Bosmin i.V.Was given and her blood pressure and consciousness recovered.Then, she was transferred to the icu, stayed overnight in the icu and left the icu the next day with a stable condition.

Manufacturer Narrative

The patient is not on chronic hemodialysis (non-hd), and the event occurred in her very first experience with this sort of extracorporeal circulation therapy.We guess a possibility of vasovagal reaction or by her mental problem due to a heavy stress, uneasiness with unexperienced treatment.The patient did not take any ace-inhibitor which is contra indicated to the ldl-a in (b)(6).However, she took a calcium antagonist as a hypotensive drug, and a concomitant ldl-a with the device might result in severe hypertension than anticipated.However, the reason of her developing such a severe hypertension cannot be clarified.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Type of Device: LDL APHERSIS SYSTEM
• Manufacturer (Section D): KANEKA CORP.; osaka ; JA
• Manufacturer (Section G): KANEKA CORP.; 2-3-18 nakanoshima; kita-ku, osaka 530- 8288; JA 530-8288
• Manufacturer Contact: masaharu inoue ; 546 fifth avenue; 21st floor; new york, NY 10036 ; 8005263522
• MDR Report Key: 3647878
• MDR Text Key: 4183972
• Report Number: 9614654-2014-00003
• Device Sequence Number: 1
• Product Code: MMY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/19/2014

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 Model Number: LA-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2014
• 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: PLASMA SEPRATOR; PLASMAFLO OP-05 ((B)(4)); NK-M3R TUBING SET ((B)(4)); MA-03 APHRESIS MACHINE ((B)(4))
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 44