MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-18 for CRRT PRISMAFLEX * manufactured by Gambro Renal Products Inc..
[2752030]
In the morning the continuous renal replacement (crrt) machine alarmed. Rn checked the alarm to find that the screen said "system malfunction. " no choices were given on the screen. The instructions stated to return the blood by crank. Rn did not do so due to the risk of clots being returned to the patient. Patient was disconnected from the machine. Machine was turned off, then back on, and at that point the rn was able to download data to the data card.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2564969 |
| MDR Report Key | 2564969 |
| Date Received | 2012-04-18 |
| Date of Report | 2012-04-18 |
| Date of Event | 2011-12-28 |
| Report Date | 2012-04-18 |
| Date Reported to FDA | 2012-04-18 |
| Date Added to Maude | 2012-05-08 |
| 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 | CRRT |
| Generic Name | CRRT |
| Product Code | MQS |
| Date Received | 2012-04-18 |
| Model Number | PRISMAFLEX |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS INC. |
| Manufacturer Address | 14143 DENVER WEST PARKWAY SUITE 400 LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-18 |