MalfunctionFII
PHOENIX
Received Jun 17, 2008 · Event occurred Oct 15, 2007
Report 1064844 · MDR key 1064844
Device
Generic name
Hemodialysis Machine
Manufacturer
Gambro Renal Products, Inc.Model number
PHOENIXCatalog number
*
Lot number
*
Product problems
- Alarm, audible
- Calibration Error
- Conductivity
- Replace
Patient
18 YR
- Therapy/non-surgical treatment, aborted/stopped
Narrative
Description of Event or Problem
SUCCESSIVE BICARB ALARM IN THE PHOENIX MACHINE #12, WHILE PATIENT WAS IN DIALYSIS, WHICH RESULTED IN CONDUCTIVITY PROBLEMS AND CAUSED PATIENT TO LOSE DIALYSIS TIME. TREATMENT RESUMED WITH ANOTHER MACHINE.