PHOENIX
Received Jun 12, 2009 · Event occurred Dec 5, 2008
Report 1405861 · MDR key 1405861
Device
Generic name
Hemodialysis Machine
Manufacturer
Gambro Renal ProductsModel number
PHOENIXCatalog number
*
Lot number
*
Product problems
- Device Inoperable
- Use of Device Problem
Patient
16 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
OPERATOR PROMPTED THE MACHINE TO USE LIQUID BICARB ONLY, AND THEN CONFIRMED THE SELECTION RENDERING THE MACHINE INOPERABLE.