MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-02 for PRISMA * manufactured by Gambro American.
[21612906]
The crrt machine was in use on the pt. There was no blood pumping from the pt and citrate filled half of the filter. The machine was stopped and the dialysis catheter was flushed. The head nurse restarted the machine and it was determined that there was a machine malfunction. The malfunction occurred four hours after the crrt was started.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1629794 |
| MDR Report Key | 1629794 |
| Date Received | 2010-03-02 |
| Date of Report | 2010-03-02 |
| Date of Event | 2009-08-17 |
| Report Date | 2010-03-02 |
| Date Reported to FDA | 2010-03-02 |
| Date Added to Maude | 2010-03-12 |
| 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 |
| 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 | PRISMA |
| Generic Name | HEMODIALYSIS, CRRT |
| Product Code | MQS |
| Date Received | 2010-03-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO AMERICAN |
| Manufacturer Address | 14143 DENVER WEST PARKWAY, SUI LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-02 |