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 2019-03-14 for LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN S-25 N/A manufactured by Kaneka Corporation.
[138895867]
Doctor's comment: since the eosinophils were 50% range, the doctor completely suspected of allergies. Due to ablation and fever, antibiotics, antipyretics and warfarin were added. Since the medications keep being administered with tapering as of (b)(6) 2019, the doctor regards that the events were not allergy caused by taking medicine. Although the cause of the events could not be specified, but no problem was observed during the treatment of hd alone without lixelle. The patient is trying to send to hematologists while the eosinophils remain high. Manufacture's narrative: some medications have been described as anaphylactic shock as a side effect. In addition, after ablation, there was a state in which the patient's physical condition was not good even with hd alone, and the patient had a fever. It is considered that the anaphylactoid symptoms such as blood pressure drop at restart of lixelle might have occurred due to vagal reflex in a poor physical condition and due to increase in extracorporeal blood volume by lixelle, although we could not specify the cause of the events.
Patient Sequence No: 1, Text Type: N, H10
[138895868]
Lixelle s-15 treatment during hemodialysis (hd) was introduced on (b)(6) 2017 without problems. Lixelle s-25, a larger size lixelle, started to use instead of s-15 on (b)(6) 2017 and was used successfully. The patient was transferred to another hospital for ablation on (b)(6) 2018 and started administration of warfarin. The first hd without lixelle after discharge on (b)(6) 2018 was performed. Although the patient felt a little sick, however he completed the hd to the end. The hd with lixelle s-25 was resumed on (b)(6) 2018. The blood pressure (bp) at the start of treatment was about 150 mmhg but dropped to about 90 mmhg. Wheezing, breathing difficulty and pallor of the face were observed. Since spo2 was 93%, oxygen inhalation was started at 2 l, however the patient caused nausea and vomiting. It was decided that the treatment was discontinued in 40 minutes from the start. Hd with lixelle s-25 was conducted again on (b)(6) 2018. The patient had a fever of 38 degrees at the start. Flu test was negative. After taking antipyretics, the treatment was started. The blood pressure was 120 mmhg at the start of treatment. One hour later, he complained of abdominal discomfort. Although the blood pressure was maintained from120 mmhg to 130 mmhg, saline was infused to the patient. Pulse 98, spo2 97%, hr99. Since the patient caused wheezing, oxygen inhalation was started at 2 l, but it was not subsided. The patient vomited 3 times even if the oxygen inhalation was raised by 3 l. It was decided that the treatment was difficult to continue and stopped, and then the patient was hospitalized. Qb: 220 ml / min, treatment hours: 4. 5, anticoagulant: heparin, one shot 750 iu, continuation rate 1000 iu/hr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808904-2019-00007 |
| MDR Report Key | 8423409 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-14 |
| Date of Report | 2019-02-21 |
| Date of Event | 2018-12-20 |
| Date Mfgr Received | 2019-02-22 |
| Date Added to Maude | 2019-03-14 |
| 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 | LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN |
| Generic Name | BETA2-MICROGLOBULIN APHERESIS COLUMN |
| Product Code | PDI |
| Date Received | 2019-03-14 |
| Model Number | S-25 |
| Catalog Number | N/A |
| 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. Hospitalization | 2019-03-14 |