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..
[1450479]
Continuous renal replacement therapy (crrt) machine alarmed continuously for high negative pressure , no access detected, and line disconnect when none of these events were happening. Pressure was -75, which should have been acceptable. Help line indicated that range was inappropriate, and directed clinician to go to recirc menu. There was no option in that menu to change range, and there was no option to resume therapy. Had to flush, then disconnect, and then recirc patient. The machine would not let us prime and restart therapy, and continually alarmed blood in line. No blood path seen. Three rn's tried to troubleshoot. Eventually, we stopped and set up new filter despite the fact there were no clots, etc. Unable to remove machine as no replacement available. Decided flawed device better than no device. Device still in room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1562051 |
| MDR Report Key | 1562051 |
| Date Received | 2009-12-13 |
| Date of Report | 2009-12-13 |
| Date of Event | 2009-11-07 |
| 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, CONTINUOUS RENAL REPLACEMENT THERAPY |
| Product Code | FII |
| Date Received | 2009-12-13 |
| Model Number | PRISMAFLEX |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| 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 |