MalfunctionFII
PHOENIX
Received Jun 17, 2008 · Event occurred Dec 8, 2007
Report 1064875 · MDR key 1064875
Device
Generic name
Hemodialysis Machine
Manufacturer
Gambro Renal Products, Inc.Model number
PHOENIXCatalog number
*
Lot number
*
Product problems
- Alarm, audible
- Repair
- Replace
- Sticking
- Device Displays Incorrect Message
Patient
18 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PHOENIX MACHINE #11 ALARMED SHOWING D2 FLOWMETER FAILURES AND FLOW BALANCE ERROR. ALL BLOOD WAS RETURNED AND PATIENT WAS TRANSFERRED TO PHOENIX MACHINE #14. DIALYSIS RESTARTED WITH NEW CIRCUIT.