MAUDE Adverse Event Report: KANEKA CORPORATION LIPOSORBER LA-40S; LIPOPROTEIN, LOW DENSITY, REMOVAL

Model Number LA-40S

Device Problem Use of Device Problem (1670)

Patient Problems Low Blood Pressure/ Hypotension (1914); Shock (2072)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

The patient took a diuretic and an angiotensin receptor blocker (arb) immediately before initiating the ldl-a procedure on the day of the event.The diuretic had been administrating for long, but the arb was newly added since 19 days before the day of the event.Accordingly, it might be possible that her bp had become more likely to drop during the ldl-a compared to before.Since the ldl-a was commenced with a high qb at 150ml/min with a high qf/qb at 40% (or a high qf of 60ml/min), it is speculated that generation of bradykinin (bk), a potent vasodilator, in the la-40s column by the so-called contact activation was enhanced, and the plasma with a higher concentration of bk was returned to the patient.The effects of hypertensive and diuretic medications together with a higher concentration of bk in the patient's body might have caused severe hyphenation resulted in a shock symptom.The physician in charge of the ldl-a commented that a bradykinin-related shock was suspected.

Event Description

The concerned device "liposorber la-40s" is not approved in the us.However, we intend to report this case as the event occurred on a similar device of "liposorber la-15 system" that is distributed in the us under pma # p910018.A female patient with familial hypercholesterolemia, who had been treated with ldl-apheresis (ldl-a) using liposorber la-40s once a week without major adverse reactions, received an ldl-a as usual on (b)(6) 2017.The ldl-a was started with a blood withdrawal rate (qb) at 150ml/min and a plasma withdrawal ratio (qf/qb) at 40%, or a plasma flow rate (qf) at 60ml/min.Her blood pressure (bp) was in a range of 140mmhg.At a processed plasma volume (ppv) of 700ml, that would be the timing when the plasma passed through the la-40s column had begun to enter into the patient, she felt sick.Her bp dropped to 117/55 mmhg in tachycardia with a pulse of 96/min.After rapid infusion of saline her bp recovered, but remained in tachycardia with the same pulse.The ldl-a was resumed at a qb of 100ml/min with a qf/qb at 15%.At a ppv of 1,000ml, she was losing consciousness and made fecal incontinence.Her bp was unmeasurable.By saline infusion and administration with steroid and vasopressor, she regained consciousness and her bp returned in a range of 100mmhg.Oxygen inhalation was initiated and her bp elevated to 140-150 mmhg with a pulse of 110-120/min.The oxygen saturation was in 90% range.The oxygen inhalation was terminated, but she immediately complained about dyspnea and the oxygen inhalation was started again.She was transferred to the other hospital and hospitalized for respiratory and heart function examination.

Manufacturer Narrative

The patient took a diuretic and an angiotensin receptor blocker (arb) immediately before initiating the ldl-a procedure on the day of the event.The diuretic had been administrating for long, but the arb was newly added since 19 days before the day of the event.Accordingly, it might be possible that her bp had become more likely to drop during the ldl-a compared to before.Since the ldl-a was commenced with a high qb at 150ml/min with a high qf/qb at 40% (or a high qf of 60ml/min), it is speculated that generation of bradykinin (bk), a potent vasodilator, in the la-40s column by the so-called contact activation was enhanced, and the plasma with a higher concentration of bk was returned to the patient.The effects of hypertensive and diuretic medications together with a higher concentration of bk in the patient's body might have caused severe hyphenation resulted in a shock symptom.The physician in charge of the ldl-a commented that a bradykinin-related shock was suspected.Additional results of investigations: the concerned device used, the liposorber la-40s ldl adsorption column, was returned and investigated.Around 10ml of the adsorption beads inside the la-40s column, that was estimated by the volume of water layer inside the column, was lost.A hole, which seemed made by being punctured by a 16g needle, was found on the mesh inside the outlet port of the column.It was found that the facility did not use the filter device required to be used in combination with the la-40s column, and accordingly a certain amount of the adsorption beads leaked out of the column was possible to enter into the patient's vein.The device history records (dhr) of the liposorber la-40s with lot no.Of lap1292-a063 was reviewed and no nonconformity or abnormality in the manufacturing processes was found.Additional comment of the attending physician: the shock occurred during the ldl-a procedure might be attributable to the patient's bad physical condition due to newly diagnosed coronary artery disease based on diabetes.The patient recovered without any after effect and has been back on the hemodialysis treatment, 3 times per week as before.To resume the ldl-a will be considered later.Per the possible leakage of the adsorption beads out of the la-40s column, the operators recognized milky color in the tubing system at the outlet of the column in the rinsing/priming process, however, it became clear before the end of the rinsing/priming process.They regarded it as air remained in the tubing system and continued into the treatment process.They usually use a syringe to remove the air remained inside the port of the la-40s column, and used without connecting the filter device, however, have never encountered any complication before.Manufacturer's final comments: although the attending physician commented that the shock occurred during the ldl-a procedure might be attributable to the patient's bad physical condition due to newly diagnosed coronary artery disease based on diabetes, an influence of elevated bradykinin concentration in the patient blood circulation by the ldl-a procedure cannot be denied.We determined that the leakage of the adsorption beads and possibly entered into the patient's vein, which was caused by human errors at the facility, could not be relevant to the reported events occurred on the patient according to the consequences afterward.

Event Description

The concerned device "liposorber la-40s" is not approved in the us.However, we intend to report this case as the event occurred on a similar device of "liposorber la-15 system" that is distributed in the us under pma # p910018.A female patient with familial hypercholesterolemia, who had been treated with ldl-apheresis (ldl-a) using liposorber la-40s once a week without major adverse reactions, received an ldl-a as usual on (b)(6) 2017.The ldl-a was started with a blood withdrawal rate (qb) at 150ml/min and a plasma withdrawal ratio (qf/qb) at 40%, or a plasma flow rate (qf) at 60ml/min.Her blood pressure (bp) was in a range of 140mmhg.At a processed plasma volume (ppv) of 700ml, that would be the timing when the plasma passed through the la-40s column had begun to enter into the patient, she felt sick.Her bp dropped to 117/55 mmhg in tachycardia with a pulse of 96/min.After rapid infusion of saline her bp recovered, but remained in tachycardia with the same pulse.The ldl-a was resumed at a qb of 100ml/min with a qf/qb at 15%.At a ppv of 1,000ml, she was losing consciousness and made fecal incontinence.Her bp was unmeasurable.By saline infusion and administration with steroid and vasopressor, she regained consciousness and her bp returned in a range of 100mmhg.Oxygen inhalation was initiated and her bp elevated to 140-150 mmhg with a pulse of 110-120/min.The oxygen saturation was in 90% range.The oxygen inhalation was terminated, but she immediately complained about dyspnea and the oxygen inhalation was started again.She was transferred to the other hospital and hospitalized for respiratory and heart function examination.

• Brand Name: LIPOSORBER LA-40S
• 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: 6642642
• MDR Text Key: 77604843
• Report Number: 9614654-2017-00008
• 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,Followup
• Report Date: 05/19/2017

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: 06/30/2017
• Device Model Number: LA-40S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: APHERESIS MACHINE KPS-8800CE; PLASMASEPARATOR PLASMACURE PE PE-08; TUBING SYSTEM FOR PLASMAPHERESIS KPD-80PP
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Weight: 61