MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-11-17 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corp..
[5030414]
The ldl-apheresis with the liposorber la-15 system (ldl-a) applied to the (b)(6) female patient (pt) for the treatment of her arterio sclerosis obliterans (aso). It was her 6th ldl-a in the 2nd session (one session usually consists of 10 times of ldl-a). The pt was on chronic hemodialysis (hd), 3 times per week, on monday, wednesday and friday, and this ldl-a was conducted on saturday in the late afternoon. The ldl-a was completed without complication except for a slight tachycardia of over 100/min. (usually in around 70/min. During ldl-a) and she went home as usual. In the late afternoon of the next day, she suffered from severe dyspnea and was transferred by an ambulance to a general hospital, that is different from the site where her ldl-a has been conducted. The family member of the pt made a phone call to the physician in charge for her ldl-a and informed of her passing away. No further information is available from the patient's family.
Patient Sequence No: 1, Text Type: D, B5
[12569892]
No information about the cause of the patient's death was available to the physician in charge for the patient's ldl-a, and according to us, and if the ldl-a was relevant to the patient's death could not be judged. The ldl-a on the day before the patient's death was completed without complications, and accordingly, we believe that no defect or malfunction of the devices used occurred during the ldl-a. It is well known that patients with arteriosclerosis obliterance (aso), or peripheral arterial occlusive disease (paod), have complications such as coronary and/or cerebral artery diseases, and also that chronic hemodialysis (hd) patients have higher risk for heart failure, cerebral vascular diseases and myocardial infarction. The device history record (dhr) of the la-15 with lot no. Lap1340 (speculated from the device record at the local distributor) was reviewed and no nonconformity or abnormality was found in its manufacturing processes. The device met its material, assembling and product specifications. Accordingly, we believe that the ldl-a was not relevant to the patient's death and a sudden aggravation of the underling disease(s) and or complication(s) may be responsible to the patient's death.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614654-2014-00013 |
| MDR Report Key | 4274192 |
| Report Source | 01 |
| Date Received | 2014-11-17 |
| Date of Report | 2014-11-17 |
| Date of Event | 2014-10-18 |
| Date Mfgr Received | 2014-10-19 |
| Date Added to Maude | 2014-11-25 |
| 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 AVE. 21ST FLOOR |
| Manufacturer City | NEW YORK NY 10036 |
| Manufacturer Country | US |
| Manufacturer Postal | 10036 |
| Manufacturer Phone | 8005263522 |
| Manufacturer G1 | KANEKA CORP. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-15 SYSTEM |
| Generic Name | LDL APHERESIS SYSTEM |
| Product Code | MMY |
| Date Received | 2014-11-17 |
| Model Number | LA-15 |
| Lot Number | LAP1340 (SPECULATED) |
| Device Expiration Date | 2018-06-30 |
| 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 | OSAKA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-11-17 |