PHOENIX
Received Jun 17, 2008 · Event occurred Sep 15, 2007
Report 1064845 · MDR key 1064845
Device
Generic name
Hemodialysis Machine
Manufacturer
Gambro Renal Products, Inc.Model number
*Catalog number
*
Lot number
*
Product problems
- Device Issue
Patient
15 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PHOENIX MACHINE #4 FAILED THE DIALYSATE PREPARATION TEST. THE PATIENT WAS DIALYZED ON ANOTHER MACHINE AND THIS MACHINE WAS REMOVED FROM SERVICE.