MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for REDSENSE ALARM UNIT AND SENSOR RA-1-RA201 manufactured by Redsense Medical Ab.
[175416007]
Patient on shift therapy with access in his av fistula, with 45 minutes left in treatment the patient was found to be covered in a decent amount of blood from his fistula. The new sensor that is placed to detect a leak did not alarm when the site began to bleed and was only discovered when the ca went to check on him.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9601327 |
| MDR Report Key | 9601327 |
| Date Received | 2020-01-17 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-12-26 |
| Report Date | 2019-12-30 |
| Date Reported to FDA | 2019-12-30 |
| Date Reported to Mfgr | 2020-01-17 |
| Date Added to Maude | 2020-01-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REDSENSE ALARM UNIT AND SENSOR |
| Generic Name | AUTONOMOUS EXTRACORPOREAL BLOOD LEAK DETECTOR/ALARM |
| Product Code | ODX |
| Date Received | 2020-01-17 |
| Catalog Number | RA-1-RA201 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REDSENSE MEDICAL AB |
| Manufacturer Address | 19049 KIPHEART DR LEESBURG VA 20176 US 20176 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |