OtherFII
PHOENIX
Received Apr 25, 2008 · Event occurred Mar 21, 2008
Report 2087532-2008-00043 · MDR key 1039590
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
83 YR
- Cardiac Arrest
- Death
Narrative
Description of Event or Problem
IN 2008, GAMBRO RECEIVED A REPORT OF A PT WHO WENT INTO CARDIAC ARREST AND DIED WHILE DIALYZING ON A PHOENIX MACHINE, SOFTWARE VERSION 3.34. EMERGENCY MEDICAL SERVICES WAS CALLED AND THE PT WAS TRANSFERRED TO THE HOSPITAL WHERE HE WAS PRONOUNCED DEAD. BOTH FACILITY'S BIOMEDICAL TECHNICIAN AND A GAMBRO TECHNICIAN INSPECTED THE MACHINE. ALL TESTS WERE WITHIN MFR'S SPECIFICATIONS.