MalfunctionFII
AQUARIUS - AUTOMATED FLUID
Received Dec 3, 2008 · Event occurred Oct 29, 2008
Report 6000002-2008-09405 · MDR key 1299227
Device
Generic name
Hemofiltration Machine
Manufacturer
Edwards LifesciencesModel number
GEF08200Catalog number
NA
Lot number
NA
Product problems
- Computer failure
Patient
UNK
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BLOOD LEAK ALARM DOESN'T WORK.