OtherFII
PHOENIX
Received Jan 22, 2008
Report 2087532-2008-00006 · MDR key 1000491
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 DECEMBER 23RD, 2007 FROM A FACILITY WHO REPORTED THAT A PHOENIX MACHINE WAS LEAKING. IT WAS UNK WHEN THE LEAK OCCURRED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION WARRANTED IN THIS EVENT. NO EVIDENCE THAT AN ALARM OCCURRED. A GAMBRO TECH INSPECTED THE MACHINE AND FOUND THAT THERE WERE SEVERAL POWER OUTAGES AND THE CONNECTOR CAME OFF OF THE BOTTOM OF THE EV2 VALVE. THE TECH RECONNECTED THE EV2 LOWER CONNECTION. HE PERFORMED T1 TEST AND BLEACH DISINFECTION.