MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-03-13 for LIPOSORBER LA015 SYSTEM LA-15 manufactured by Kaneka Corporation.
[4299983]
Te ldl-apheresis (ldl-a) with liposorber la-15 system was applied to the patient (pt) for the treatment of his arterio sclerosis obliterans (aso). He has developed cholesterol crystal embolization (cce) after receiving a percutaneous coronary intervention (pci). He rec'd the first ldl-a on (b)(6) (10 days ago), and it was his second treatment with the ldl-a. He also developed disseminated intravascular coagulation syndrome (dic) developed, and a gastrointestinal bleeding was observed on the day of the ldl-a. On the day of the event, he rec'd first a continuous hemodiafiltration (chdf) followed by the ldl-a in icu. At the start of the ldl-a procedure, he had already a difficulty to breath normally with mandibular-breathing, edema of the whole body, lower level of consciousness, and the blood pressure (bp) was 90mmhg. His bp further dropped during the ldl-a, and he developed a very severe hypotension to become unconscious, and cardiopulmonary arrest at around one (1) hour after starting the procedure. The ldl-a was immediately terminated, cardiac compression was performed, adrenalin was given by intracardiac injection, and cardiac compression was continued, but the patient died. The time course of the ldl-a on that day was as follows: 11:15 (am), the ldl-a was initiated with the operating conditions of the blood flow rate (qb) with 70ml/min and a plasma filtration ratio (qf) of 20% (14ml/min). The patient's bp was 90mmhg, 11:40, his bp dropped to 60mmhg from 70mmhg and qb was reduced to 60ml/min. , at around 500ml of processing plasma volume, 11:50, no sign of his bp's going up was seen, 12:00, qb was further reduced to 50ml/min. , at around 800ml of processing plasma volume, 12:10, his bp dropped to 30-40mmhg and the operating nurse called the doctor for the termination of the treatment. At 12:15, the nurse stopped the pumps of the apheresis machine and intended to return the blood and the plasma to the patient; however, the patient's condition suddenly deteriorated to become unconscious with cardiac arrest and performed cardiac compression. Adrenaline was given by intracardiac injection and cardiac compression was continued; however, patient died.
Patient Sequence No: 1, Text Type: D, B5
[11550321]
According to the physician in charge, the patient had developed dic, gastrointestinal bleeding necessitated with blood transfusion, and his physical status was very poor with mandibular breathing, lower bp with lower consciousness level when the ldl-a was started after a chdf. The physician in charge commented that the patient's death was not attributable to the ldl-a itself taking into account the circumstances of the patient's physical conditions although it could not completely be excluded since the hypotension resulted finally in the patient's death occurred during the ldl-a procedure. We believe that the patient's physical condition on the day of the event was too poor and intolerable to the ldl-a procedure, and accordingly, the patient's death is attributable neither to the device failure nor the ldl-a itself with the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614654-2014-00004 |
| MDR Report Key | 3678702 |
| Report Source | 01,05 |
| Date Received | 2014-03-13 |
| Date of Report | 2014-03-04 |
| Date of Event | 2014-02-24 |
| Date Added to Maude | 2014-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 LA015 SYSTEM |
| Generic Name | LDL APHERESIS SYSTEM |
| Product Code | MMY |
| Date Received | 2014-03-13 |
| 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 CORPORATION |
| Manufacturer Address | OSAKA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-03-13 |