MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-11-17 for ASAHI REXEED SERIES DIALYZERS REXEED-21R manufactured by Asahi Kasei Kuraray Medical Co., Ltd..
[1780252]
The pt was treated on hemodialysis using the rexeed-21r dialyzer on (b)(6) 2010. The dialysis equipment alarmed the blood leakage two or three minutes after starting the extracorporeal circulation. The blood circulation was stopped immediately. The dialyzer (the product from the same box) and the blood tube set were replaced and the dialysis treatment was started again. But the equipment warned the blood leakage again in the same timing as the first time. The dialyzer (the product from the same box) and the tube set were changed to new ones, and the treatment was tried again. But the equipment detected the blood leakage again. In the fourth time, the new dialyzer picked up from the different box. But the blood leak was detected just after restarting the blood circulation. The pt lost about the 1000ml of blood because the 250ml of blood remained in the dialyzer and blood tubing set was discarded each time. The blood transfusion was needed for the pt in the additional hospital day.
Patient Sequence No: 1, Text Type: D, B5
[8929547]
We checked the quality records including the material incoming inspections, in-process tests and the product release inspection. However, no abnormality was found. The leakage test was performed on each product during the manufacturing process. And non-conforming products are not released from the plant. So the broken hollow fiber that may cause the blood leakage could be cause by inadequate condition of transportation, storage, and/or handling of products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010002-2010-00001 |
| MDR Report Key | 1960219 |
| Report Source | 99 |
| Date Received | 2010-11-17 |
| Date of Report | 2010-11-15 |
| Date of Event | 2010-10-14 |
| Date Mfgr Received | 2010-10-15 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2012-03-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JUNICHI HAYAMA, VP |
| Manufacturer Street | 3000 DUNDEE RD. STE 320 |
| Manufacturer City | NORTHBROOK IL 60062 |
| Manufacturer Country | US |
| Manufacturer Postal | 60062 |
| Manufacturer Phone | 8474988500 |
| Manufacturer G1 | OITA WORKS, ASAHI KASEI KURARAY MEDICAL CO., LTD. |
| Manufacturer Street | 2111-2 OAZA SATO |
| Manufacturer City | OITA SHI 870-0396 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 870-0396 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASAHI REXEED SERIES DIALYZERS |
| Generic Name | HEMODIALYZER, RE-USE, HIGH FLUX; MSF |
| Product Code | MSF |
| Date Received | 2010-11-17 |
| Model Number | REXEED-21R |
| Lot Number | M88N8U |
| Device Expiration Date | 2011-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASAHI KASEI KURARAY MEDICAL CO., LTD. |
| Manufacturer Address | TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-11-17 |