MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-13 for * REXEED-25S manufactured by Asahi Kasei Medical America Inc..
[18640607]
Dialysis treatment was initiated and a possible blood leak was noted at drain. Hemo stick with negative result. Treatment was stopped, blood not returned, and a new system along with machine started. Patient lost approximately 250 ml of blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4449907 |
| MDR Report Key | 4449907 |
| Date Received | 2015-01-13 |
| Date of Report | 2015-01-13 |
| Date of Event | 2015-01-08 |
| Report Date | 2015-01-13 |
| Date Reported to FDA | 2015-01-13 |
| Date Reported to Mfgr | 2015-01-26 |
| Date Added to Maude | 2015-01-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | HEMODIALYZER |
| Product Code | MSF |
| Date Received | 2015-01-13 |
| Model Number | REXEED-25S |
| Catalog Number | * |
| Lot Number | WB4Y4G |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASAHI KASEI MEDICAL AMERICA INC. |
| Manufacturer Address | 3570 WINCHESTER ROAD, SUITE 10 MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-13 |