MalfunctionFII
AQUARIUS - AUTOMATED FLUID
Received Nov 24, 2008 · Event occurred Oct 23, 2008
Report 6000002-2008-09339 · MDR key 1297684
Device
Generic name
Hemofiltration Machine
Manufacturer
Edwards LifesciencesModel number
GEF08200Catalog number
NA
Lot number
NA
Product problems
- Application Program Problem: Dose Calculation Error
- Application Program Problem: Parameter Calculation Error
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
REPORTEDLY, IT DOES NOT RECORD THE TREATMENT. THE CLIENT SAYS THAT THE EQUIPMENT TAKES MORE FLUID THAN PROGRAMMED.
Additional Manufacturer Narrative
DEVICE NOT RETURNED.