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..
[62678481]
Anaphylactoid reactions with severe hypotension including shock during the ldl-a procedure with liposorber la-15 system are known as one of severe side effects, especially in patients who are concomitantly medicated with ace-inhibitors, which are attributed to the dextran sulfate-cellulose gels (or the ingredient of the "liposorber la-15 ldl adsorption columns"). In japan, patients being treated with any ace-inhibitor is contra-indicated to the ldl-a procedures with this device. It was revealed that the patient had been prescribed with an ace-inhibitor in other hospital, and the physicians conducted the ldl-a on this patient without aware of the fact that the patient was under the influence of an ace-inhibitor. Accordingly, we believe that the event was caused by a use error to apply the device against its contra-indication, and not by any defect or malfunction of the device. The actual device used was not available for our further investigation.
Patient Sequence No: 1, Text Type: N, H10
[62678482]
This incident occurred in (b)(6). The ldl-apheresis (ldl-a) with liposorber la-15 system was applied to a hypercholesterolemic patient with arterio- sclerosis obliterans (aso). The patient developed a shock symptom with a severe hypotension at around 15 minutes after starting the ldl-apheresis. The ldl-a procedure was immediately terminated and the patient's blood pressure was stabilized by administering adrenaline. It was revealed later that the patient had been prescribed in other hospital with ace-inhibitor, that is contra-indicated to this ldla procedure in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2016-00020 |
| MDR Report Key | 6183190 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-16 |
| Date of Report | 2016-09-09 |
| Date of Event | 2016-09-08 |
| Date Mfgr Received | 2016-09-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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, OSAKA |
| Manufacturer Country | JA |
| Manufacturer Phone | 4613072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| 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 Age | DA |
| 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 |