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..
[62639913]
Since the ldl-a is necessary to take a certain amount of the blood outside the patient's body to circulate through the extracorporeal circuit, the volume of blood circulating in the patient's body decreases, and it may cause a hypovolemia. In this reported case, the ldl-a was started despite the patient's bp was already very low, and the decrease in circulating blood volume inside the patient by initiating the ldl-a was considered to cause the severe hypotension. The patient's vital conditions on the day of the event might be not tolerable to this sort of extracorporeal treatment. The ifu of the liposorber la-15 system for fsgs (distributed in usa) provides information about hypotension as an adverse event that may be associated with the use of the system. Physician's comment: although we have enough experiences of ldl-a with the liposorber la-15 system, the patient's renal function got worse rapidly and the timing to initiating ldl-a was too late. When we may resume ldl-a on this patient, make sure to initiate ldl-a after appropriately stabilizing the patient's bp.
Patient Sequence No: 1, Text Type: N, H10
[62639914]
The ldl-apheresis with the liposorber la-15 system (ldl-a) and a hemodialysis were introduced to the patient with nephrotic syndrome due to focal glomerulosclerosis (fsgs), whose renal condition was suddenly aggravated after administrating with cyclosporine. On the day of the first ldl-a, the patient was carried into the treatment room with laying on the bed and felt tired, her blood pressure (bp) was on 80s (mmhg) measurable by a manipulation (her bp could not be measurable by a cannulation). The blood side of the extracorporeal circuit of the ldl-a was first filled with 25% albumin and the blood withdrawal was initiated with nafamostat mesilate (futhan) as an anticoagulant. After circulation only the blood for a while, the ldl-a was commenced at a blood flow of 100ml/min and a plasma separation ratio of 10%. Upon the operating nurse's repetitive calls to the patient, she replied very tired and her bp became low to 40mmhg. On continuing the ldl-a, her condition worsened and she lost consciousness with dilated pupil. Immediately, saline was infused and oxygen inhalation was started. While shaking the patient, she regained consciousness and could react to calling her name. The ldl-a was discontinued and the blood in the extracorporeal circuit was returned to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2016-00006 |
| MDR Report Key | 6183188 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-16 |
| Date of Report | 2016-02-17 |
| Date of Event | 2016-02-17 |
| Date Mfgr Received | 2016-02-17 |
| 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 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 | 3 |
| Brand Name | LIPOSORBER LA-15 SYSTEM |
| Generic Name | LIPOPROTEIN, LOW DENSITY, REMOVAL |
| Product Code | MMY |
| Date Received | 2016-12-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2016-12-16 |