OtherFII
PHOENIX
Received Feb 6, 2008 · Event occurred Jan 1, 2008
Report 2087532-2008-00012 · MDR key 1015269
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 REC'D A COMPLAINT ON JANUARY 07TH, 2008 FROM A FACILITY WHO REPORTED THAT A PHOENIX MACHINE WAS LEAKING PROFUSELY FROM THE BOTTOM. IT WAS UNKNOWN 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 TECHNICIAN INSPECTED THE MACHINE AND FOUND THAT THE HOSE ON THE BOTTOM OF EVUFO WAS DISCONNECTED. HE REPLACED IT AND BLEACH CLEANED THE UNIT.