PHOENIX
Received Aug 20, 2008 · Event occurred Jun 30, 2008
Report 2087532-2008-00086 · MDR key 1140023
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
- Death
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT A PT EXPIRED WHILE DIALYZING ON A PHOENIX MACHINE, SOFTWARE VERSION 3.34. ACCORDING TO THE FACILITY'S CHARGE NURSE, IT IS THE POLICY OF THIS DCI CLINIC NOT TO PROVIDE INFO RELATED TO PT DEATHS AND IT IS ALSO THEIR POLICY TO HAVE THE MACHINE IN USE AT THE TIME OF A PT DEATH REMOVED FROM SVC AND INSPECTED BY THE MFR'S TECHNICAL SVC REP BEFORE IT CAN BE USED AGAIN. A GTS REP INSPECTED THE PHOENIX MACHINE AND FOUND NO PROBLEM WITH THE MACHINE. THE GTS REP. CONCLUDED THAT THE MACHINE WAS OPERATING WITHIN MFR'S SPEC. THE MACHINE WAS RETURNED TO SVC.