MalfunctionFII
GAMBRO PHOENIX
Received May 12, 2008 · Event occurred Mar 17, 2008
Report 1047458 · MDR key 1047458
Device
Generic name
Hemodialysis Machine
Manufacturer
Gambro Inc.Model number
PHOENIXCatalog number
*
Lot number
*
Product problems
- Alarm, audible
- False Alarm
- Repair
Patient
3 YR
- No Patient Involvement
Narrative
Description of Event or Problem
AFTER PRESSING "PATIENT CONNECT" BUT BEFORE PATIENT WAS ACTUALLY CONNECTED, AIR IN BLOOD LINE ALARM OCCURRED. ATTEMPTED TO CLEAN VENOUS SENSOR BUT ALARM CONTINUED. TROUBLESHOOTING SHOWED POTENTIAL PROBLEM WITH ABD (AIR BUBBLE DETECTOR) MODULE, SO IT WAS REPLACED.