MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-16 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corp..
[62677736]
It is known that rare but some patients may develop iron deficiency anemia during repetitive ldl-apheresis (ldl-a) procedures due to cumulative blood loss by the residual blood in the extracorporeal circuit and blood sampling for chemistry in every ldl-a procedure. It is presumed that this particular patient developed and worsened anemia in the similar circumstances. The ifu of the hud liposorber la-15 provides information about anemia saying that "on the occurrence of anemia, it can be minimized by the supplementation of iron. " however, an anemia is likely multifactorial in etiology, related to medications, chronic disease, malnutrtion, and ongoing nephrosis, and the contribution of the ldl-a procedure to this patient's anemia is not surely confirmed. According to the physician in charge, the patient had received a total of 17 ldl-a procedures as of the date of this event and the patient's clinical response to the treatment had been so far good, and accordingly, the ldl-a on this patient would be continued weekly or biweekly basis. His anemia is ameliorated in grade2 in the end of (b)(6). This report is delayed because it was sent to the emdr test instead of production.
Patient Sequence No: 0, Text Type: N, H10
[62677737]
The patient is a (b)(6) boy who has been treated by the ldl-apheresis with liposorber la-15 system approved as a humanitarian use device (hud) for his treatment of recurrent nephrotic syndrome associated with focal segmental glomerulosclerosis (fsgs) post renal transplantation. He has developed anemia and received exogenous erythropoietin but this was not optimally effective. After his 17th treatments with the ldl-apheresis, his anemic condition worsened into grade3 anemia (his hemoglobin level fell below 7g/dl) and required a prbc transfusion.
Patient Sequence No: 0, Text Type: D, B5
| Report Number | 9614654-2015-00015 |
| MDR Report Key | 6183186 |
| Date Received | 2016-12-16 |
| Date of Report | 2015-11-20 |
| Date of Event | 2015-10-20 |
| Date Mfgr Received | 2015-11-22 |
| 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 | 0 |
| Reprocessed and Reused Flag | 0 |
| 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 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 | APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN PEDIATRIC PATIENTS |
| Product Code | PBN |
| Date Received | 2016-12-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| 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 |
|---|---|---|---|
| 0 | 0 | 1. Required No Informationntervention | 2016-12-16 |