MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-25 for LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN S-35 manufactured by Kaneka Corporation.
[63259751]
This patient had been tolerated well with lixelle until 26th treatments. The cause of fever, chills, tachycardia is unknown. After administration of antibiotics, these symptoms ceased and there is a possibility that some kind of infection might have occurred. The column size of lixelle was stepwise increased from s-15, s-25 and then to s-35, and this incident occurred when the largest s-35 was used. The possibility of the decrease in blood pressure accompanied by increase in extracorporeal circulation volume cannot be denied.
Patient Sequence No: 1, Text Type: N, H10
[63259752]
The patient was a male patient on chronic hemodialysis (hd), and had received hd with lixelle, 3 times per week, since (b)(6) 2016. The column size of the lixelle used was increased from s-15 (150ml), s-25 (250ml) and then to s-35 (350ml). On (b)(6) 2016 (in the previous treatment with lixelle s-35, 2 days before the date of this incident) he alleged symptoms at around 20 min. Before the end of the treatment. He was tachycardic, had more chills with fever (around 101. 5 f). He refused to go to er and got chest x ray done at that time. He felt better after getting antibiotics (vanco 1g & cefepime 2g since he was allergic to gentamycin. ). Because infection was suspected, a blood culture was done (the results was negative as of (b)(6) 2016). On (b)(6) 2016, it was his 28th treatments with lixelle, where s-35 was used, he complained mild chills with fever of 101. 2 f towards the end of the treatment. Vanco 1g & cefepime 2g iv were given after the treatment and his symptoms ceased. A blood culture was done again. He has had fluid overload since the previous treatment (700ml positive because he was given considerable amount of normal saline post hd due to hypotension). However, he had remained hypotensive. Sbp checked between 70 and 80mmhg (lying down). O2 sat 94% with oxygen 3l/min via nc. He decided to go to er. He was hospitalized on (b)(6) 2016 and has being hospitalized since then.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2016-00024 |
| MDR Report Key | 6203743 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-25 |
| Date of Report | 2016-12-01 |
| Date of Event | 2016-11-28 |
| Date Mfgr Received | 2016-12-16 |
| Date Added to Maude | 2016-12-25 |
| 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 | 31814120 |
| 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 | 2016-12-25 |
| Catalog Number | S-35 |
| 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 | 2016-12-25 |