InjuryFII
PHOENIX
Received Apr 15, 2008 · Event occurred Apr 14, 2008
Report 1029650 · MDR key 1029650
Device
Generic name
Dialysis Machine, Crrt
Manufacturer
Gambro Renal Products, Inc.Model number
PHOENIXCatalog number
*
Lot number
*
Product problems
- Device Alarm System
- Conductivity
Patient
16 YR
- Seizures
- Hospitalization required
Narrative
Description of Event or Problem
THIS PATIENT WAS RECEIVING DIALYSIS WHEN THE CONDUCTIVITY GOT OUT OF RANGE. THE MACHINE FAILED TO ALARM AND THE PATIENT HAD A SEIZURE RESULTING IN AN OVERNIGHT ADMISSION TO PICU.====================== MANUFACTURER RESPONSE FOR DIALYSIS MACHINE, CRRT, PHOENIX======================THEY ARE CONCERNED. I'M SURE THEY WILL COME TO OUR FACILITY AND LOOK OVER THE PROBLEMS WE ARE HAVING.