MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-17 for REDSENSE ALARM SYSTEM manufactured by Redsense Medical, Inc..
[1826292]
Redsense sensor and monitor applied to pt for "not in direct line of sight" hemodialysis treatment. Treatment proceeded for three hours without problems then hemodialysis machine alarmed. When staff entered room, pt's needle had dislodged and bleeding from access site was occurring rapidly. Redsense monitor did not alarm -no audible tones- but all lights on monitor were illuminated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018651 |
| MDR Report Key | 1936845 |
| Date Received | 2010-12-17 |
| Date of Report | 2010-12-17 |
| Date of Event | 2010-11-12 |
| Date Added to Maude | 2010-12-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REDSENSE ALARM SYSTEM |
| Generic Name | REDSENSE ALARM SYSTEM |
| Product Code | ODX |
| Date Received | 2010-12-17 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REDSENSE MEDICAL, INC. |
| Manufacturer Address | 150 N MICHIGAN AVE. SUITE 1950 CHICAGO IL 60601 US 60601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2010-12-17 |