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 2016-12-16 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corp..
[62639921]
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.
Patient Sequence No: 1, Text Type: N, H10
[62639922]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2016-00009 |
| MDR Report Key | 6183189 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-16 |
| Date of Report | 2016-03-28 |
| Date of Event | 2016-03-17 |
| Date Added to Maude | 2016-12-16 |
| 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-15 SYSTEM |
| Generic Name | LIPOPROTEIN, LOW DENSITY, REMOVAL |
| Product Code | MMY |
| Date Received | 2016-12-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KANEKA CORP. |
| Manufacturer Address | 2-3-18,NAKANOSHIMA,KITA-KU OSAKA CITY 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2016-12-16 |