MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-12 for * PRISMAFLEX manufactured by Gambro Renal Products, Inc.
[20158445]
During the evening the prismaflex continuous renal replacement therapy (crrt) machine went down with reported error of "malfunction: blood pump - incorrect rate". Following return from ct, machine had been in recirculating mode. An attempt was made to reprime machine as directed by machine to resume therapy, at which point error occurred, thus requiring the set up of an additional circuit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1562059 |
| MDR Report Key | 1562059 |
| Date Received | 2009-12-12 |
| Date of Report | 2009-12-12 |
| Date of Event | 2009-09-12 |
| Report Date | 2009-12-12 |
| Date Reported to FDA | 2009-12-12 |
| 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 | 2009-12-12 |
| Model Number | PRISMAFLEX |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 5 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 | 2009-12-12 |