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 2016-12-16 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corp..
[62678646]
The doctor in charge said that the cause of her death was myocardial infarction and was not attributable to the ldl-a. As the physician stated she died of myocardial infarction. However, her later development of myocardial infarction might have been relevant to a sudden change in her physical condition during the ldl-a such as dyspnea. Futhan shock, bradykinin related anaphylactoid reaction, etc. Might be possible causes of the sudden change in her physical condition during the ldl-a. The antibody test to futhan on the day before the event was negative, whereas the result of the allergic test to futhan of the patient was not available. The bradykinin related anaphylactoid reaction can be denied because of the use of futhan as an anticoagulant during the ldl-a on the event. Futhan is known to suppress bradykinin generation during the ldl-a. Although the physician in charge commented that the ldl-a was not relevant to the patient's death, a possibility that the ldl-a was relevant to the catastrophic events occurred during the ldl-a cannot, we consider, be completely excluded.
Patient Sequence No: 1, Text Type: N, H10
[62678647]
The subject is a hemodialysis patient complicated with arteriosclerosis obliterans (aso). She has a history of diabetes and was put on a pacemaker. She was treated by ldl-apheresis (ldl-a) using liposorber la-15 system for the treatment of aso. It was her 6th ldl-a treatment of the 3rd course of ldl-a when the event occurred. Usually one course of ldl-a on aso consists of 10 treatments. Her physical condition changed suddenly and she caused dyspnea at about 50min after starting ldl-a. The extracorporeal blood was returned to her immediately. Since even after bronchial intubation and oxygen inhalation she did not recover, she was transferred to the general hospital which this dialysis center was an affiliate of. The values of oxygen saturation were 98% at the start of ldl-a and 70% at the onset of event. Her systolic blood pressure was 90mmhg usually before ldl-a and was 120mmhg at the onset of the event. Futhan (or nafamostat mesilate), a protease inhibitor, was used as the anticoagulant of ldl-a since the 3rd ldl-a converting from heparin, because she developed a feeling of breathing difficulty during ldl-a under heparin, which might have caused by increase in bradykinin generation. The result of the antibody test on futhan was negative on the day before the event. Ldl-a conditions on the day of the event: the blood flow rate (qb) was 100ml/.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2016-00022 |
| MDR Report Key | 6183191 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-16 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-10-19 |
| Date Mfgr Received | 2016-10-19 |
| 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 | 3 |
| 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, OSAKA 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 |
| Model Number | LA-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-12-16 |