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 2017-06-18 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corporation.
[77822651]
The actual la-15 ldl adsorption columns used was returned and investigated. No abnormality by visual examinations was observed. The manufacturing records (dhr) of the device based on the lot and serial numbers of the devices concerned was reviewed and no nonconformities was observed. After confirming that some portions of the hollow fibers of the sulfux fp-08 plasmaseparator were colored in purple, and the plasmaseparator was sent to the manufacturer, asahi-kasei medical, for their investigations. The physician in charge commented that the plasmaseparator might have been attributable to the reported patient's reactions. However, we cannot completely exclude a possibly that the ldl-a procedure is relevant to the acute hypotension occurred since the extracorporeal volume in the ldl-a is larger than that of a hemodialysis procedure.
Patient Sequence No: 1, Text Type: N, H10
[77822652]
The patient was on a maintenance hemodialysis and complicated with peripheral artery disease (pad) and diabetes, who had completed one set of ldl-apheresis (ldl-a) sessions using liposorber la-15 system for the treatment of pad before without problem. It was the first ldl-a procedure of the second set of ldl-a sessions, and the patient went into anaphylactic shock accompanied by hypotension down to 70-80mmhg (normally 120-130mmhg) 30 minutes after start of the ldl-a, or at 500ml of treated plasma volume. Some parts of the hollow fibers of the plasmaseparator, sulflux fp-08, appeared colored in purple instead of usual white in the completion of plasma/blood return procedure after the treatment. The patient was administered with a supplementation fluid and steroid when entered into the shock, and the symptom subsided. Heparin was used for an anticoagulant during the ldl-a. The patient was administered with an antidiarrhoic, loperamide, and did not take any angiotensin converting enzyme (ace) inhibitor. After the events during ldl-apheresis, the patient keeps receiving maintenance hemodialysis as usual.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2017-00006 |
| MDR Report Key | 6649382 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-06-18 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-04-21 |
| Date Added to Maude | 2017-06-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2017-06-18 |
| Returned To Mfg | 2017-04-24 |
| Model Number | LA-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Life Threatening | 2017-06-18 |