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 2018-02-13 for LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN S-15 N/A manufactured by Kaneka Corporation.
[99996143]
As possible causes for arrhythmia during the treatment with lixelle, in general, situations as follows are considered: hypokalemia or hyperkalemia, occurrence accidentally based on the past history of arrhythmia, and/or decrease in trough level of digoxin, anti-arrhythmic drug, due to adsorption to the lixelle during the treatment. The lixelle is confirmed in clinical investigations that the use of lixelle is unlikely to influence on the trough level of potassium. The patient's blood chemistry for potassium before and after the occurrence of the arrhythmia was not available. It is confirmed that the patient does not have history of arrhythmia and accordingly does not take digoxin. Accordingly, possible causes for the arrhythmia resulted in lost consciousness during the treatment with lixelle on this patient is not clear. However, we cannot completely exclude the relevance of the use of lixelle to the event reported, and we determine the case as mdr reportable.
Patient Sequence No: 1, Text Type: N, H10
[99996144]
This device, lixelle beta2-microglobulin apheresis column (lixelle), was introduced to a (b)(6) years of age female patient on chronic hemodialysis for 27 years for the treatment of her dialysis related amyloidosis (dra). The reported event occurred on the very first treatment with lixelle. For this treatment, a hemodialysis module was changed to fx-cordiax 140 (fresenius) from renak ps 1. 6 (kawasumi) in order to reduce the total priming volume. The patient showed mood discomfort 10 minutes before the end of the treatment, was recognized arrhythmia, and then lost consciousness. The patient was given i. V. 300ml of physiological saline and then, she became responding to voice call in 8 minutes after her lost consciousness, and her arrhythmia ceased. Additional 200ml of physiological saline was given and her mood discomfort disappeared in 30 minutes after her lost consciousness. Since then, the patient is continued on hemodialysis without lixelle by using renak ps 1. 6.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808904-2017-00015 |
| MDR Report Key | 7269107 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-02-13 |
| Date of Report | 2018-01-18 |
| Date of Event | 2018-01-15 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2017-06-14 |
| Date Added to Maude | 2018-02-13 |
| 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 | 4613072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN |
| Generic Name | BETA2-MICROGLOBULIN APHERESIS COLUMN |
| Product Code | PDI |
| Date Received | 2018-02-13 |
| Model Number | S-15 |
| Catalog Number | N/A |
| Lot Number | BMP1506 |
| Device Expiration Date | 2019-05-28 |
| 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 OSAKA, 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-02-13 |