MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-22 for PRISMAFLEX * manufactured by Gambro.
[14884271]
The continuous renal replacement therapy (crrt) machine failed two self-tests. During the last failure an error 24 came up and then it said 24 volt/12 volt. We are awaiting a mfr. Response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2399554 |
| MDR Report Key | 2399554 |
| Date Received | 2011-12-22 |
| Date of Report | 2011-12-21 |
| Date of Event | 2011-12-05 |
| Report Date | 2011-12-21 |
| Date Reported to FDA | 2011-12-22 |
| Date Added to Maude | 2012-01-05 |
| 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 | PRISMAFLEX |
| Generic Name | CRRT |
| Product Code | MQS |
| Date Received | 2011-12-22 |
| Model Number | PRISMAFLEX |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Manufacturer Address | 14143 DENVER WEST PARKWAY SUITE 400 LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-22 |