MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-13 for * PRISMAFLEX manufactured by Gambro Renal Products, Inc..
[1450481]
Patient was on continuous renal replacment therapy (crrt). I pushed patient fluid removal from the flow rates screen to set my next hourly rate and patient fluid removal highlighted in red, but the rate did not. The screen would not change from this setup for 13 minutes. The only button that was able to be pushed was "enter", but that did not happen until after the 13 minutes. When "enter" was pushed and activated, the status screen reappeared. When i pushed flow rates on the status screen to adjust the patient fluid removal rate, a memory error 6 occurred. The blood pump stopped and the therapy was disconnected from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1562055 |
| MDR Report Key | 1562055 |
| Date Received | 2009-12-13 |
| Date of Report | 2009-12-13 |
| Date of Event | 2009-11-03 |
| Report Date | 2009-12-13 |
| Date Reported to FDA | 2009-12-13 |
| Date Added to Maude | 2009-12-18 |
| 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 | HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPY |
| Product Code | FII |
| Date Received | 2009-12-13 |
| Model Number | PRISMAFLEX |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | 14143 DENVER WEST PARKWAY, SUI LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-13 |