MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-08 for PRISMAFLEX * N/A manufactured by Gambro Renal Products.
[1423152]
Gambro prismaflex suddenly alarmed air detected then it gave message stop treatment and call for servicing. The renal fellow was called and renal rn obtained replacement prismaflex which would not boot up. There was only a air detected warning to call service. A third machine was obtained which functioned. The total time the crrt (continuous renal replacement therapy) machine was down was three hours and forty-five minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1599164 |
| MDR Report Key | 1599164 |
| Date Received | 2010-02-08 |
| Date of Report | 2010-02-08 |
| Date of Event | 2010-01-13 |
| Report Date | 2010-02-08 |
| Date Reported to FDA | 2010-02-08 |
| Date Added to Maude | 2010-02-15 |
| 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 | PRISMAFLEX |
| Generic Name | HEMODIALYSIS, CRRT |
| Product Code | MQS |
| Date Received | 2010-02-08 |
| Model Number | * |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS |
| Manufacturer Address | 14143 DENVER WEST PARKWAY SUITE 400 LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-08 |