MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-01-13 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corp..
[4213575]
The ldl-apheresis (ldl-a) with liposorber la-15 system was applied to the pt (pt) on chronic hemodialysis (hd) for the treatment of arterio sclerosis obliterance (aso). In the first ldl-a, the pt developed a shock symptom at the very beginning of the procedure and the procedure was immediately terminated. They found that the pt was prescribed with an ace-inhibitor (enalato:enalapril maleate). The second ldl-a was conducted by one-week cessation of the ace-inhibitor, however, the pt developed again a similar shock symptom.
Patient Sequence No: 1, Text Type: D, B5
[11485693]
Anaphylactoid reactions with severe hypotension including shock are known as one of side effects, especially in patients who are concomitantly treated with ace-inhibitors, which are attributed to the dextran sulfate-cellulose gels or the ingredient of the "liposorber la-15 ldl adsorption columns". In (b)(6), patients being treated with any ace-inhibitor is contra-indicated to the ldl-apheresis with this device. In our investigation, the pt was found taking an ace-inhibitor, "enalato", and the apheresis unit conducted the ldl-apheresis with this device without being aware of the fact that the pt was taking the ace-inhibitor. Accordingly, we believe that the event was caused by a user error to use the device against contra-indication and not be any defect or malfunction of the device. The actual device used was not available for our further investigation. The pt is on chronic hemodialysis (hd) with renal failure, and the effectiveness of the ace-inhibitor had remained longer than usual at the second event after one week cessation of the ace-inhibitor. Currently no more ldl-apheresis procedure with this device is schedule n this pt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614654-2014-00001 |
| MDR Report Key | 3571229 |
| Report Source | 01,05 |
| Date Received | 2014-01-13 |
| Date of Report | 2014-01-07 |
| Date of Event | 2013-12-10 |
| Date Added to Maude | 2014-01-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MASAHARU INOUE |
| Manufacturer Street | 546 FIFTH AVENUE 21ST FLOOR |
| Manufacturer City | NEW YORK NY 10036 |
| Manufacturer Country | US |
| Manufacturer Postal | 10036 |
| Manufacturer Phone | 8005263522 |
| Manufacturer G1 | KANEKA CORP. |
| Manufacturer Street | 2-18-3 NAKANOSHIMA |
| Manufacturer City | KITA-KU, OSAKA 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 530-8288 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-15 SYSTEM |
| Generic Name | LDL APHERESIS SYSTEM |
| Product Code | MMY |
| Date Received | 2014-01-13 |
| Model Number | LA-15 |
| Lot Number | UNK |
| 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 | OSAKA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-13 |