MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2002-04-18 for LIPOSORBER LA-15 COLUMN 977-00-00 manufactured by Kaneka Corp.
[280506]
The incident occurred in 2002. The pt has chronic renal failure, and on chronic hemodialysis for 5 years. For the treatment of "arteriosclerosis obliterans with hyperlipidemia", pt started receiving ldl-apheresis in 2001 and 10 ldp-asphereis procedures (one term of the therapy) were successfully conducted. The second term of additional 10 ldl-apheresis was prescribed and started in 2002. The incident occurred on the 4th ldl-apheresis in the second term therapy. The pt died 10 minutes after starting the procedure at 178ml of processed plasma volume. The cause of death was determined as "acute heart failure" by the physician in charge, although the liposorber la-15 system was not totally excluded as cause of death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2002-00001 |
| MDR Report Key | 389434 |
| Report Source | 01,05 |
| Date Received | 2002-04-18 |
| Date of Report | 2002-04-18 |
| Date of Event | 2002-03-20 |
| Date Mfgr Received | 2002-03-20 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2002-04-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 3-2-4, NAKANOSHIMA, KITA-KU |
| Manufacturer City | OSAKA 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 530-8288 |
| Manufacturer Phone | 62265228 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-15 COLUMN |
| Generic Name | LIPOSORBER LA-15 SYSTEM |
| Product Code | MMY |
| Date Received | 2002-04-18 |
| Model Number | LA-15 |
| Catalog Number | 977-00-00 |
| Lot Number | LAP706 |
| ID Number | NA |
| Device Expiration Date | 2005-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 378482 |
| Manufacturer | KANEKA CORP |
| Manufacturer Address | 3-2-4, NAKANOSHIMA, KITA-KU OSAKA JA 530-8288 |
| Baseline Brand Name | LIPOSORBER LA-15 COLUMN |
| Baseline Generic Name | LDL ADSORPTION SYSTEM |
| Baseline Model No | LA-15 |
| Baseline Catalog No | 797-100-000 |
| Baseline ID | NA |
| Baseline Device Family | LIPOSORBER LA-15 SYSTEM |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9100 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2002-04-18 |