MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-20 for CRRT MACHINE PRISMAFLEX NOT APPLICABLE manufactured by Gambro Renal Products, Inc..
[19904758]
The healthcare practitioner entered the room to retrieve the previous hours ultrafiltration reading and all of the soft keys locked up and would not work. Immediately following, the continuous renal replacement therapy (crrt) machine alarmed and stated malfunction (six). It would not allow the practitioner to override the alarm. An attempt was made to give the blood back to the patient. Downloaded data and shut off the machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941545 |
| MDR Report Key | 1941545 |
| Date Received | 2010-12-20 |
| Date of Report | 2010-12-20 |
| Date of Event | 2010-11-30 |
| Report Date | 2010-12-20 |
| Date Reported to FDA | 2010-12-20 |
| Date Added to Maude | 2010-12-29 |
| 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 | CRRT MACHINE |
| Generic Name | CRRT MACHINE |
| Product Code | FII |
| Date Received | 2010-12-20 |
| Model Number | PRISMAFLEX |
| Catalog Number | NOT APPLICABLE |
| Lot Number | NOT APPLICABLE |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1.6 YR |
| 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 | 2010-12-20 |