MalfunctionFII
EDWARDS BM25RENT (BM 11A/BM14)
Received Feb 9, 2009 · Event occurred Nov 26, 2008
Report 6000002-2009-09847 · MDR key 1374184
Device
Generic name
Acute Blood Purification Hemofiltration Machine
Manufacturer
Edwards LifesciencesModel number
BM25RENTCatalog number
NA
Lot number
NA
Product problems
- Alarm, audible
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
REPORTEDLY, CONTINUOUS BALANCE ALARM.
Additional Manufacturer Narrative
EXCHANGED BALANCE MODULE, NEW CALIBRATION, FUNCTION TEST. TEST RUN - OK.
Remedial action
- Repair