MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-02-07 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corporation.
[4094505]
The ldl-apheresis (ldl-a) with liposorber la-15 system was applied to a (b)(6) years of age female patient (hd), with diabetes mellitus (dm) and dementia, for the treatment of her arterio sclerosis obliterans (aso). In the first ldl-a of the pt, she developed a severe hypotension with a shock symptom at around 10-15 minutes after starting the procedure (at 11:07 am), and the procedure was immediately terminated. The pt fell into a temporary cardiac arrest and an automated external defibrillator (aed) was applied, saline was infused i. V. , and her blood pressure (bp) gradually elevated and stayed at 70-80 mmhg (at around 12:00). Her bp recovered to 120 mmhg and she was put on a hd procedure (12:20) and completed the hd without problem (at 15:30). On the same day, her cardio thoracic ratio (ctr) was confirmed normal by an x-ray examination and she went home with no aftereffect of the incident. The pt was administered with an ace-inhibitor (lokopool: lisinopril), and the ldl-a on this day was conducted after one week-cessation of the ace-inhibitor.
Patient Sequence No: 1, Text Type: D, B5
[11515462]
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 contraindicated to the ldl-apheresis (ldl-a) with this device. In our investigation, the patient (pt) was prescribed with an ace-inhibitor, "lokopool", and the pt was applied to the ldl-a with this device after one week-cessation of the ace-inhibitor. The pt is on chronic hemodialysis (hd) with renal failure, and the effectiveness of the ace-inhibitor had remained longer than usual, and one week-cessation seemed insufficient to eliminate the influence of the ace-inhibitor. Her second ldl-a with this device was successfully done two weeks after this event with continuous cessation of the ace-inhibitor by using nafamostat mesilate, "futhan", as an anticoagulant. Accordingly, we believe that the event was caused by a use 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614654-2014-00002 |
| MDR Report Key | 3613156 |
| Report Source | 01,05 |
| Date Received | 2014-02-07 |
| Date of Report | 2014-01-31 |
| Date of Event | 2014-01-07 |
| Date Added to Maude | 2014-02-10 |
| 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 CORPORATION |
| Manufacturer Street | 2-3-18,NAKANOSHIMA,KITA-KU |
| Manufacturer City | 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 | 2014-02-07 |
| Model Number | LA-15 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KANEKA CORPORATION |
| Manufacturer Address | OSAKA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-07 |