MAUDE Adverse Event Report: KANEKA CORP. LIPOSORBER LA-15 SYSTEM; APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN PEDIATRIC PATIENTS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Anemia (1706); Test Result (2695)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Type of Device: APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN PEDIATRIC PATIENTS
• Manufacturer (Section D): KANEKA CORP.; 2-3-18,nakanoshima,kita-ku; osaka 530-8 288; JA 530-8288
• Manufacturer Contact: kazuhiko inoue ; 2-3-18 nakanoshima,kita-ku; osaka 530-8-288 ; JA 530-8288 ; 4613072
• MDR Report Key: 6183186
• MDR Text Key: 62677736
• Report Number: 9614654-2015-00015
• Device Sequence Number: 0
• Product Code: PBN
• Reporter Country Code: US
• PMA/PMN Number: H120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2015
• Initial Date FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Treatment: APHERESIS MACHINE KANEKA MA-03; SULFLUX KP-05 PLASMA SEPARATOR; TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(U)
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 42