MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-06-15 for LIPOSORBER LA-40S manufactured by Kaneka Corporation.
[77604843]
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.
Patient Sequence No: 1, Text Type: N, H10
[77604844]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2017-00008 |
| MDR Report Key | 6642642 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-06-15 |
| Date of Report | 2017-05-19 |
| Date of Event | 2017-05-17 |
| Date Added to Maude | 2017-06-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KAZUHIKO INOUE |
| Manufacturer Street | 2-3-18,NAKANOSHIMA, KITA-KU, |
| Manufacturer City | OSAKA-CITY, 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 530-8288 |
| Manufacturer Phone | 4613072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-40S |
| Generic Name | LIPOPROTEIN, LOW DENSITY, REMOVAL |
| Product Code | MMY |
| Date Received | 2017-06-15 |
| Returned To Mfg | 2017-05-23 |
| Model Number | LA-40S |
| Device Expiration Date | 2017-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KANEKA CORPORATION |
| Manufacturer Address | 2-3-18, NAKANOSHIMA, KITA-KU, OSAKA-CITY, 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2017-06-15 |