OtherFII
PHOENIX
Received Apr 22, 2008 · Event occurred Mar 1, 2008
Report 2087532-2008-00034 · MDR key 1044681
Device
Generic name
Hemodialysis Equipment
Manufacturer
Gambro DascoModel number
PHOENIXCatalog number
6023006700
Lot number
NA
Product problems
- Disconnection
- Fluid/Blood Leak
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
GAMBRO REC'D A COMPLAINT ON MARCH 14, 2008 FROM A FACILITY WHO REPORTED THAT A PHOENIX MACHINE, SOFTWARE VERSION 3.34, WAS LEAKING. IT WAS UNK WHEN THE LEAK OCCURRED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION WARRANTED IN THIS EVENT. NO EVIDENCE THAT A TUBE DISCONNECTION RELATED ALARM OCCURRED. A GAMBRO TECH INSPECTED THE MACHINE AND FOUND THAT TUBING DISCONNECTED AT INPUT OF FILTER F7, CAUSING EXTERNAL FLUID LEAK. HE RECONNECTED TUBING AND VERIFIED PROPER OPERATION THROUGH BLEACH ADR CYCLE.