OtherFII
PHOENIX
Received Nov 14, 2007 · Event occurred Oct 12, 2007
Report 2087532-2007-00215 · MDR key 976284
Device
Generic name
Hemodialysis Equipment
Manufacturer
Gambro DascoModel number
PHOENIXCatalog number
6023006700
Lot number
NA
Product problems
- Fluid/Blood Leak
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
GAMBRO RECEIVED A COMPLAINT ON 10/15/07 FROM A FACILITY WHO REPORTED THAT A PHOENIX MACHINE WAS LEAKING DURING TREATMENT. A GAMBRO TECH INSPECTED THE MACHINE AND FOUND THAT THE TUBING WAS DISCONNECTED BETWEEN PFS AND EVDS1 VALVE AND AT EVUFO VALVE. HE RECONNECTED THE TUBING AT THE PFS/EVDS1 VALVE AND THE EVUFO VALVE. HE RAN THE MACHINE THROUGH T1 TEST, A SIMULATED PT RUN AND AN ADR BLEACH DISINFECT CYCLE.