MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-20 for LIPOSORBER LA-15 SYSTEM N/A manufactured by Kaneka Corporation.
[136597756]
The events occurred at the plasma treatment volume of 279 ml just after the plasma passed through la-15 column was returned to the patient. The kidney function of the patient with recurrent fsgs after renal transplantation might have been deteriorated. Since ace inhibitor, enalapril, was discontinued three days before the first la-15 treatment, it is considered that the washout period was not long enough due to decrease in renal function of the patient. Thus, the events were most likely caused by the elevation of bradykinin in plasma passing through la-15 column together with the inhibition of the degradation of bradykinin by remaining ace-inhibitor in the patient's blood. It is not necessarily judged as serious adverse events from each symptom reported, however the patient was conveyed to er, so that we considered that the events correspond to serious adverse events in total.
Patient Sequence No: 1, Text Type: N, H10
[136597757]
A (b)(6) y. O boy with recurrent fsgs post-transplant. Has been receiving plasmapheresis up until today. Gfr well below 60 but a moot point in post-transplant; serum creatinine 2. 9; serum protein 4. 6; albumin 3. 5; h&h 9. 2, 28. 6; 305 platelets. He was on ace-i (enalapril) and off for 72 hours according to his mother. He had a double lumen ij patent with good flows. Plasma volume tb treated 4,200 ml (90kg x 60ml). 1. 8 u heparin for bolus and 1. 8 u heparin during treatment (25 u per kg). Two alarms early on for venous pressure which were quickly remedied with a flush. His mother states that one of the ports was not working well and the nurses doing the plasmapheresis only used one of the ports. Started at 60ml bfr and 20% pfr. Treatment started at 09:48 vss 125/76-84-16 skin warm and dry color normal at 10:04, 16" into treatment, patient complained of chest pain and started thrashing in the bed; color pale lips cyanotic even though pulse ox 100%. The patient was lowered the head of the bed got o2 non rebreather mask; stopped the pumps had rn give 100 cc bolus normal saline (ns); code called and nurses gave solu medrol 125 and dr. Wanted 500 cc bolus ns given. Vs were 154/84-129-24. Patient within 5 minutes felt better. 10:28 bp 128/78-72. Patient transferred to the er. Patient stable after 30 to 40". It was very first experience on him with liposorber switched from plasma exchange (the last pex was jan 14).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808904-2019-00005 |
| MDR Report Key | 8352832 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-20 |
| Date of Report | 2019-01-25 |
| Date of Event | 2019-01-25 |
| Date Mfgr Received | 2019-01-25 |
| Date Added to Maude | 2019-02-20 |
| 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. YOSHIYUKI KITAMURA |
| Manufacturer Street | 2-3-18 NAKANOSHIMA, KITA-KU |
| Manufacturer City | OSAKA-CITY, OSAKA 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 530-8288 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-15 SYSTEM |
| Generic Name | APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN ADULT AND PEDIATRIC PATIENTS |
| Product Code | PBN |
| Date Received | 2019-02-20 |
| Model Number | LA-15 |
| Catalog Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KANEKA CORPORATION |
| Manufacturer Address | 2-3-18 NAKANOSHIMA, KITA-KU OSAKA-CITY, OSAKA 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Other | 2019-02-20 |