MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-07-12 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corp..
[2816429]
The pt has chronic renal failure and receives consecutive dialysis therapy. She also had the arteriosclerosis obliterans (aso). To treat the aso, the pt received ldl-apheresis therapy with the liposorber la-15 and plasmaflo (b)(4) for the first time. Before the ldl-a therapy on 1st of (b)(6) 2012, the pt was treated with the peripheral vascular intervention (ppi) to the left ata. The cag wasn't done during the ppi treatment. The adverse event happened when the plasma was processed by 141ml. The blood pressure dropped from 124/49 to 67/35mmhg and the heart rate dropped from 55 to 34. The pt suffered the cardiac arrest and became unconsciousness when the symptoms advanced. The defibrillation sulfate was administered to the pt. The pt was resuscitated after the coronary intervention. She was hospitalized and recovered. The la-15 system used in usa is composed of a tubing set, a hollow fiber plasma separator (plasmaflo kp-05) and two dextran sulfate ldl-adsorption columns, these are disposable and only intended for single use. The ma-03 machine is controlled by the computer.
Patient Sequence No: 1, Text Type: D, B5
[9984193]
The used devices could not be evaluated because, they were discarded after the event. The lot number was not confirmed. The processed plasma didn't return to the pt because of the incident (141ml). Mfr confirmed that the pt didn't take an ace-inhibitor, but a hypertensive diuretic. Just before the ldl-a therapy, the pt was treated with the ppi to the left ata for the first time. The investigation reported that the clinical condition of the pt may have caused the adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614654-2012-00001 |
| MDR Report Key | 2659378 |
| Report Source | 01,05 |
| Date Received | 2012-07-12 |
| Date of Report | 2012-07-09 |
| Date of Event | 2012-03-01 |
| Date Added to Maude | 2012-07-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TAKASHI YAMASHITA |
| Manufacturer Street | 3-2-4,NAKANOSHIMA,KITA-KU |
| Manufacturer City | OSAKA 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 530-8288 |
| Manufacturer Phone | 62265256 |
| Manufacturer G1 | KANEKA PHARMA AMERICA LLC. |
| Manufacturer Street | 546 FIFTH AVENUE 21ST FLOOR |
| Manufacturer City | NEW YORK NY 10036 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 10036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-15 SYSTEM |
| Generic Name | LDL ADSORPTION SYSTEM |
| Product Code | MMY |
| Date Received | 2012-07-12 |
| 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. Hospitalization; 2. Required No Informationntervention | 2012-07-12 |