MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-17 for PRISMAFLEX * NA manufactured by Gambro Renal Products, Inc..
[17470350]
Filter change due. Therapy was stopped, and the same patient was selected. Priming procedure initiated and completed. There was an air in blood alarm given without soft keys to clear alarm. (air detector should be disabled during priming) the cassette had to be unloaded, and the data card was downloaded. A new patient was selected and circuit was primed easily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1597633 |
| MDR Report Key | 1597633 |
| Date Received | 2010-01-17 |
| Date of Report | 2010-01-17 |
| Date of Event | 2009-12-15 |
| Report Date | 2010-01-17 |
| Date Reported to FDA | 2010-01-17 |
| Date Added to Maude | 2010-02-10 |
| 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 | HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPY |
| Product Code | MQS |
| Date Received | 2010-01-17 |
| Model Number | * |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 8 MO |
| 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 | 2010-01-17 |