MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-16 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corp..
[62669501]
On the previous day of the event ldl-apheresis with the concerned device was completed without any complication. Next day, the patient completed hemodialysis and spent hours in his patient's room normally before the event occurred. Then, the patient suddenly lost consciousness and entered into cardiopulmonary arrest. Therefore, it is speculated that sudden death occurred after some catastrophic events. No information about the cause of death of the patient was provided. On fsgs, the causes of death in general are reported as follows: malignant tumors for 1. 4%, infectious disease for 0. 7%, abdominal aortic aneurysm-rupture for 0. 4%, heart failure for 0. 4%, and sudden death for 0. 4%. (the japanese journal of nephrology, vol. 44, pp 751-761, 2002. ) although the physician in charge commented that ldl-apheresis could not be relevant to the patient's death, we cannot completely exclude a possibility that ldl-apheresis and/or hemodialysis is relevant to the catastrophic events occurred.
Patient Sequence No: 1, Text Type: N, H10
[62669502]
A maintenance hemodialysis patient with new-onset of focal glomerulosclerosis (fsgs). No other complications were observed. As steroid was not effective on fsgs, ldl-apheresis therapy using the liposorber a-15 system was commenced. On (b)(6) his 8th ldl-apheresis was conducted. On (b)(6) he underwent hemodialysis without any complication, returned to his patient's room and took a meal. He had a conversation normally, although he confessed slightly ill. Then, he suddenly lost consciousness at 15:30, and suffered cardiopulmonary arrest. He recovered once after resuscitation, but died at 16:07.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2016-00001 |
| MDR Report Key | 6183187 |
| Date Received | 2016-12-16 |
| Date of Report | 2015-12-09 |
| Date of Event | 2015-12-04 |
| Date Mfgr Received | 2015-12-09 |
| 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 | 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 | 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 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-12-16 |