MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-16 for PRISMAFLEX N/A manufactured by Gambro Renal Products, Inc..
[19463645]
The dialysate bag was changed and five minutes later there was an excess fluid loss/gain alarm sound. No alarms between bag change and the excess fluid loss gain. There was no chance to troubleshoot. The filter had to be taken down and a new one put up. The data card was downloaded and the system was restarted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1595824 |
| MDR Report Key | 1595824 |
| Date Received | 2010-01-16 |
| Date of Report | 2010-01-15 |
| Date of Event | 2009-12-16 |
| Report Date | 2010-01-15 |
| Date Reported to FDA | 2010-01-16 |
| Date Added to Maude | 2010-02-08 |
| 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 MACHINE, CONTINOUS RENAL REPLACEMENT THERAPY |
| Product Code | MQS |
| Date Received | 2010-01-16 |
| Model Number | PRISMAFLEX |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 8 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 | 2010-01-16 |