MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-10 for LIPOSORBER LA-15 SYSTEM N/A manufactured by Kaneka Corporation.
[91806524]
A fsgs patient with intractable nephrotic syndrome is usually administered first with steroid to assess if the patient is steroid-resistant, and when the patient is judged steroid-resistant, ldl-apheresis will be introduced under continued administration with steroid, as so this particular patient was. Accordingly, the patient had already been susceptible to infection before and throughout the ldl-apheresis therapy. It was reported that the ldl-apheresis up to 9th procedures had completed without any problem in out-patient basis. The patient developed fever the next day of the 9th ldl-apheresis, and was in-hospitalized with increase in wbc counts and escherichia coli positive in the blood cultivation. We strongly suspect that the infection was caused through the tunneled catheter for blood access placed for over 40 days when the reported incident occurred. We believe that the contribution of the ldl-apheresis procedure itself to the infection is quite unlikely. The attending physician commented that the relationship between the ldl-apheresis and the reported event is "possibly related". Since we could not completely decline the relevance between the ldl-apheresis and the incident, we decided to make a mdr as a case which were required hospitalization. We believe this incident is attributable not to defect or malfunction of the devices but to the aggravation of the infection through the long-standing tunneled catheter.
Patient Sequence No: 1, Text Type: N, H10
[91806525]
A pediatric patient developed focal segmental glomerular sclerosis (fsgs) with steroid resistant nephrotic syndrome. A tunneled catheter for blood withdrawing was placed at right internal jugular vein on (b)(6) 2017 for commencing ldl-apheresis using the liposorber la-15 system. The ldl-apheresis up to 9th on (b)(6) was conducted without any problem in out-patient basis. Since the patient had fever on the next day of 9th ldl-apheresis, she was admitted to the hospital for further examination and medication. Her wbc was 34200/microliter and the result of the blood culture was escherichia coli positive, which was found to become negative after administration of antibiotics. The 12th ldl-apheresis, the final session, on (b)(6) was over without any problem. The attending physician was planning to discharge the patient after removing the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808904-2017-00005 |
| MDR Report Key | 7016810 |
| Date Received | 2017-11-10 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-10-12 |
| Device Manufacturer Date | 2017-02-02 |
| Date Added to Maude | 2017-11-10 |
| 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, OSAKA 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 530-8288 |
| Manufacturer Phone | 31814120 |
| 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 | 2017-11-10 |
| Model Number | LA-15 |
| Catalog Number | N/A |
| Lot Number | LAP1445 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KANEKA CORPORATION |
| Manufacturer Address | 2-3-18, NAKANOSHIMA, KITA-KU, OSAKA-CITY, 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2017-11-10 |