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..
[1452289]
Continual alarms on continuous renal replacment therapy (crrt) machine for "access extremely negative" for last 24 hours (or more). There were frequent reset-ups and recircing done. Renal fellow aware and was considering new device. Upon arrival this am, i attempted to troubleshoot the filter. I clamped the arterial access and used 0. 9 normal saline flush wide open as arterial source. However, the machine continued to have "access extremely negative" alarm. Continued to run by pushing continue multiple times, and was able to give him most of his blood back. No large clots seen in the system. Dialysis rn called to look at machine. Set up and machine saved, and left on. Biomed called and was advised to turn off machine, dispose of set up, put tag on machine, and put in back room. New crrt machine to be used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1562239 |
| MDR Report Key | 1562239 |
| Date Received | 2009-12-12 |
| Date of Report | 2009-12-12 |
| Date of Event | 2009-10-10 |
| Report Date | 2009-12-12 |
| Date Reported to FDA | 2009-12-12 |
| Date Added to Maude | 2009-12-21 |
| 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 | 6 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 |