MalfunctionFII
AQARIUS - AUTOMATED FLUID
Received Jan 23, 2009 · Event occurred Nov 26, 2008
Report 6000002-2009-09731 · MDR key 1352966
Device
Generic name
Acute Blood Purification Hemofiltration Machine
Manufacturer
Edwards LifesciencesModel number
GEF08200Catalog number
NA
Lot number
NA
Product problems
- Inaccurate Flow Rate
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
REPORTEDLY, TAKING TOO MUCH FLUID FROM PATIENT.
Additional Manufacturer Narrative
EVALUATION SUMMARY: RECALIBRATED ALL PRESSURES AND SCALES. MACHINE PASSING SELF TEST. SUBSTITUTION SCALE. SYSTEM. FILTRATE SCALE. SYSTEM. FILTRATE PRESSURE SENSOR. SYSTEM. ACCESS PRESSURE SENSOR. SYSTEM - CALIBRATION ERROR.