MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-02-03 for LIPOSORBER LA-15 SYSTEM N/A manufactured by Kaneka Corporation.
[134858599]
Since the plasma treatment volume was 400 ml, the plasma treated by liposorber column had already returned to the patient's body. The ace inhibitor (perindopril) was withdrawn 3 days before liposorber treatment. However, perindoprilat, the active metabolite of perindopril, is a substance which remains in the blood even after 3 days of the withdrawal. In spite of not taking other antihypertensive drugs, blood pressure was maintained at 110 mmhg from the day of drug cessation. Based on these evidences, it is considered that the effect of the ace inhibitor was sustained even after the withdrawal. The implementation of liposorber treatment in patients taking ace inhibitors is alerted in ifu's contra-indications.
Patient Sequence No: 1, Text Type: N, H10
[134858600]
A (b)(6), male, non hemodialysis patient. The first liposorber treatment on cholesterol crystal embolization. Fifteen minutes after the start of treatment which is about 400 ml of plasma treatment, blood pressure drop (from 110 mmhg to 70 mmhg) and loss of consciousness occurred. Urgent return of blood was conducted and the treatment was discontinued. The unconsciousness lasted about several seconds and the patient was recovered with 400 ml of saline supplement. Other symptoms such as feeling uncomfortable, nausea, vomiting, etc were also observed. Since ace inhibitor (perindopril) was administered 3 days before treatment, 30 mg/h of futhan (nafamostat mesilate) was used as an anticoagulant. Since bicornuate (bicarbonate ringer's solution) was used for the washing solution, futhan was not used for priming. No abnormality in the vital sign before treatment and no dehydration was observed. After withdrawal of ace inhibitor, no other antihypertensive drugs were administered. Blood pressure was maintained at 110 mmhg level even after withdrawal of ace inhibitor. The doctor suspected allergies of futhan, liposorber or sulflux (plasma separator).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808904-2018-00023 |
| MDR Report Key | 8300586 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-02-03 |
| Date of Report | 2019-01-09 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2018-09-03 |
| Date Added to Maude | 2019-02-03 |
| 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 | LIPOPROTEIN, LOW DENSITY, REMOVAL |
| Product Code | MMY |
| Date Received | 2019-02-03 |
| Model Number | LA-15 |
| Catalog Number | N/A |
| Lot Number | LAP1512 |
| 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. Other | 2019-02-03 |