MalfunctionFII
AQUARIUS (REGULAR)
Received Oct 31, 2008 · Event occurred Sep 25, 2008
Report 6000002-2008-09115 · MDR key 1220820
Device
Generic name
Acute Blood Purification Machine
Manufacturer
Edward LifesciencesModel number
GEF09600Catalog number
NA
Lot number
NA
Product problems
- Malfunction
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
REPORTEDLY, IF YOU HAVE CHOSEN "NO ANTICOAGULATION" IT IS POSSIBLE TO PROGRAM HEPARIN IN PROGRAMMING. IT SHOULD NOT BE POSSIBLE.
Additional Manufacturer Narrative
DEVICE NOT RETURNED.