MalfunctionFII
PHOENIX
Received Aug 13, 2009 · Event occurred Jun 16, 2009
Report 1444662 · MDR key 1444662
Device
Generic name
Hemodialysis
Manufacturer
Gambro Renal Products, IncModel number
*Catalog number
*
Lot number
*
Product problems
- Pumping Stopped
Patient
20 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE MOTOR BLOOD PUMP OF THE DIALYSIS MACHINE STOPPED WORKING, EVEN AFTER ATTEMPTING TO TROUBLESHOOT IT. THE BLOOD HAD TO BE RETURNED MANUALLY. THERE WAS NO BLOOD LOSS NOTED AND THE PATIENT VITAL SIGNS WERE STABLE. TREATMENT WAS DELAYED FOR ABOUT 30 MINUTES. HEMODIALYSIS RESUMED WITH NEW PREPARED MACHINE, LINES, AND DIALYZER.