MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-13 for * PRISMAFLEX manufactured by Gambro Renal Products, Inc..
[1394846]
Continous renal replacement therapy (crrt) machine alarming effluent volume too high/low 330cc. When attempted to correct alarm, prompted to discontinue treatment due to volume being reached. No other prior alarms noted for effluent volume in past hour. Blood returned to patient and current system taken down. Upon retrieving numbers for the hour, discovered machine set for 550cc patient fluid removal. However, machine removed 780cc of fluid for an additional net loss of 230cc with no alarms given for additional fluid loss. Biomed notified of malfunctioning machine and new machine ordered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1562045 |
| MDR Report Key | 1562045 |
| Date Received | 2009-12-13 |
| Date of Report | 2009-12-13 |
| Date of Event | 2009-11-11 |
| Report Date | 2009-12-13 |
| Date Reported to FDA | 2009-12-13 |
| Date Added to Maude | 2009-12-18 |
| 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 | 2009-12-13 |
| Model Number | PRISMAFLEX |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| 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 | 2009-12-13 |