PHOENIX
Received Nov 9, 2007 · Event occurred Oct 12, 2007
Report 2087532-2007-00210 · MDR key 956640
Device
Generic name
Hemodialysis Equipment
Manufacturer
Gambro DascoModel number
PHOENIXCatalog number
6023006700
Lot number
NA
Product problems
- Normal
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Loss of consciousness
Narrative
Description of Event or Problem
GAMBRO RECEIVED A COMPLAINT IN 2007 FROM A FACILITY WHO REPORTED THAT A HOSPITALIZED ADULT PT CODED WHILE DIALYZING ON A PHOENIX MACHINE. PER DCI POLICY THE MACHINE WAS PULLED FROM SERVICE. ABOUT 3 DAYS LATER, A GAMBRO SERVICE TECH INSPECTED THE MACHINE AND FOUND NO PROBLEMS WITH THE MACHINE. THE MACHINE WAS AUTHORIZED TO RETURN TO SERVICE. THE MACHINE HAS BEEN USED CLINICALLY WITH NO FURTHER PROBLEMS. LAB TESTS TO VERIFY DIALYSATE COMPOSITION WERE CONDUCTED AT THE TIME OF THE INCIDENT. THE RESULTS WERE SATISFACTORY INDICATING THAT THE DIALYSATE WAS OF THE CORRECT COMPOSITION AT THE TIME OF THE INCIDENT.