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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION LIPOSORBER LA-15 SYSTEM; APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN PEDIATRIC PATIENTS, PRODUCT CODE: PBN
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KANEKA CORPORATION LIPOSORBER LA-15 SYSTEM; APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN PEDIATRIC PATIENTS, PRODUCT CODE: PBN Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Anemia (1706)
Event Date 11/20/2015
Event Type  Injury  
Event Description
The patient is a (b)(6) years old 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.Mfr# 9614654-2015-00015.
 
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Brand Name
LIPOSORBER LA-15 SYSTEM
Type of Device
APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN PEDIATRIC PATIENTS, PRODUCT CODE: PBN
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18, nakanoshima, kita-ku,
osaka, osaka 530-8 288,
JA  530-8288,
MDR Report Key12056964
MDR Text Key258041506
Report Number2435151-2021-00003
Device Sequence Number1
Product Code PBN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/22/2021,06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/22/2021
Distributor Facility Aware Date11/20/2015
Event Location Hospital
Date Report to Manufacturer11/24/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/24/2021
Type of Device Usage N
Patient Sequence Number1
Treatment
APHERESIS MACHINE KANEKA MA-03; SULFLUX KP-05 PLASMA SEPARATOR; TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(U)
Patient Outcome(s) Required Intervention;
Patient Age14 YR
Patient Weight42
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