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 2018-11-14 for LIXELLE S-15 N/A manufactured by Kaneka Corporation.
[127209926]
The increase in extracorporeal circulation volume due to the combination of lixelle column to compare with dialysis only may cause a decrease in blood pressure although saline administration as supplementation fluid did not improve the decreased bp so much. Since the treatment conditions of lixelle had not been changed until (b)(6) when the abrupt decrease in bp was reported for the first time, the cause is unknown.
Patient Sequence No: 1, Text Type: N, H10
[127209927]
Event narrative: lixelle s-15 in combination with a dialyzer was used for the treatment of dialysis-related amyloidosis. Lixelle treatment with dialysis (lixelle) started from (b)(6) 2017, and had been conducted without problems. On (b)(6) 2018 lixelle for 4 hours was planned. The patient complained of constipation and loss of appetite before lixelle. Since blood pressure (bp) dropped to 80 mmhg and symptoms such as, cold sweats, nausea, headache, stomachache, etc were observed during the treatment, the lixelle was terminated in 3 hours. A total of 700 ml of saline was administered during the lixelle. On (b)(6), (b)(6), (b)(6), and (b)(6), hemodialysis treatments only were conducted. Bp during the hemodialysis was stable at around 150 mmhg. On (b)(6) lixelle was resumed and at the start bp was 159 mm hg. At 15 min after lixelle bp decreased to 116 mmhg, and 100ml of saline was administered. At 30 min bp decreased to 81 mmhg. At 40 min the patient complained of feeling bad, and 100 ml of saline was administered. The bp was 90 mmhg. At 45 min bp was 78 mmhg, and 200 ml of saline was administered. At 80 min bp was 105 mmhg. Even after administration of saline bp showed no recovery. Lixelle was terminated at 80 min. On (b)(6) hemodialysis treatment only was tried for 5 hours and was found to be no problem. Other complications: cholesterol crystal embolization on (b)(6) 2015 pta of right lower limb thrombosis on (b)(6) 2015 and (b)(6) 2015 amputation of lower limb on (b)(6) 2016 ldl apheresis for 10 times from (b)(6) 2015, and ldl apheresis for 10 times from (b)(6) 2017. Chocolate cyst. Spinal canal stenosis. Fever on the day of dialysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808904-2018-00018 |
| MDR Report Key | 8072411 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-14 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-09-03 |
| Date Mfgr Received | 2018-10-19 |
| Date Added to Maude | 2018-11-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | BETA2-MICROGLOBULIN APHERESIS COLUMN |
| Product Code | PDI |
| Date Received | 2018-11-14 |
| Model Number | S-15 |
| 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; 2. Other | 2018-11-14 |