MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-04-28 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corp..
[5821185]
The case is (b)(6) male pt on maintenance hemodialysis. The ldl-apheresis therapy with the liposorber la-15 system (ldl-a) was commenced for the treatment of his arterio sclerosis obliterans (aso) on an outpatient basis on (b)(6) 2015. The pt was treated by ldl-a for the third time on (b)(6) 2015, and the treatment finished without problem and he went home. The next day, he developed arrhythmia with torsades de pointes, and admitted to the icu diagnosed with worsening of heart failure. Cpk elevation was observed from 105 iu / l (measurement date unk) to 1449 iu / l. Although acute myocardial infarction was suspected, no significant coronary stenosis was found by coronary angiography. Then, he felt at ease and was discharged from the hosp (date unk).
Patient Sequence No: 1, Text Type: D, B5
[13436077]
The next (4th) ldl-a was conducted on (b)(6) (15 days after the reported event). On the same day, he underwent hemodialysis after the ldl-a. Immediately after the hemodialysis was over, cyanosis on peripheral limbs, and the lips were developed and then the symptoms were subsided. Blood pressure was stable during the ldl-a, and also in the hemodialysis. Since then, ldl-a therapy was suspended, and only hemodialysis has been continued without problem, as of (b)(6). Probable cause of event: about 400ml blood circulation volume may be increased by the blood and plasma return at the end of the ldl-a procedure, anda possibility that the increase in heart load led to development of arrhythmia and worsening of heart failure transiently can not be denied. The other possible cause may be the side effects of concomitant medications; although all drugs could not be confirmed, one of the possibilities of such side effects is that of nafamostat mesylate used as an anticoagulant only during ldl-a. Our comment: all four times ldl-a treatments had been completed without any abnormalities, and the event occurred the next day of the 3rd ldl-a. Since the pt had medical histories of arrythmia, heart failure and cardiovascular disease, we believe that the ldl-a procedure is not relevant to the event, but it's contribution to the event could not totally be denied.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614654-2015-00007 |
| MDR Report Key | 4749841 |
| Report Source | 01,05 |
| Date Received | 2015-04-28 |
| Date of Report | 2015-04-28 |
| Date of Event | 2015-03-04 |
| Date Mfgr Received | 2015-04-06 |
| Date Added to Maude | 2015-05-06 |
| 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 FL |
| 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 | 2015-04-28 |
| 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 CORP. |
| Manufacturer Address | OSAKA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-04-28 |