MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-25 for LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN manufactured by Kaneka Corporation.
[63620382]
Since the lixelle and the connecting tube are pvp free, a possibility of developing pvp allergy can be excluded. Those devices are steam sterilized and a possibility of ethylene oxide (eto) allergy can also be excluded. The incident occurred in the very first treatment with lixelle s-15. According to the treatment parameters provided by the treatment site, the patient was overhydrated by 3. 3 kg (6. 3%) to the estimated ideal weight (b)(6) before starting the treatment. Due to his overhydrated condition, a relatively higher dehydration rate at 700-1,000 ml/hr compared to that in standard hd procedures (500-700 ml/hr in general), with the blood flow rate of 230 ml/min, was applied. Since the lixelle is used connecting in series to a hemodialyzer, the extracorporeal volume (the blood circulating outside the body) increases by a priming volume of the lixelle s-15 from that of the hd system alone. It might be possible that a higher dehydration rate and the increased extracorporeal volume enhanced a hypovolemic status to cause the severe hypotension resulting in a shock symptom. This report is delayed because it was sent to the emdr test instead of production.
Patient Sequence No: 1, Text Type: N, H10
[63620383]
The case was a male patient on his 60s of age with chronic hemodialysis (hd) accompanied with dialysis-related amyloidosis (dra). When an on-line hemodiafiltration (hdf) was introduced to the patient in order to improve worsened symptoms of dra, he experienced a significant hypotension at 30 min. After beginning the treatment. The blood test revealed that he was positive in allergy to polyvinylpyrrolidone (pvp). The hdf was switched to a hemodialysis (hd) by using a polysulfone hemodialyzer, aps (asahi kasei medical), but a significant hypotension reoccurred in 12th or 13th hd with the aps, and then, the hemodialyzer was changed to a cellulose triacetate hemodialyzer, fb-190ub (nipro), and the complication had not recurred since then. Since his dra exacerbated again, lixelle s-15, beta2-microglobuline adsorption column, was added on the hd with the fb-190ub. In his first hd with the lixelle, his blood pressure (bp) dropped from 148 mmhg to 72 mmhg at about one hour after starting the treatment and he fell into a state of shock. The treatment was stopped immediately and he recovered with a saline infusion. His bp returned to 130's mmhg at the termination of the treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2016-00007 |
| MDR Report Key | 6203729 |
| Date Received | 2016-12-25 |
| Date of Report | 2016-02-24 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2016-02-24 |
| 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 | 4613072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN |
| Generic Name | BETA2-MICROGLOBULIN APHERESIS COLUMN |
| Product Code | PDI |
| Date Received | 2016-12-25 |
| 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. Life Threatening | 2016-12-25 |