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..
[21400598]
Machine kept alarming for filter; could not detect access and no blood flow in path. Filter eventually unable to run.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1562048 |
MDR Report Key | 1562048 |
Date Received | 2009-12-13 |
Date of Report | 2009-12-13 |
Date of Event | 2009-11-08 |
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 | 1 DY |
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 |