MalfunctionFII
COBE C3-PLUS
Received May 12, 2008 · Event occurred Jan 30, 2007
Report 1052006 · MDR key 1052006
Device
Generic name
Hemodialysis Machine,
Manufacturer
Gambro Renal Products, Inc.Model number
C-3-PLUSCatalog number
*
Lot number
*
Product problems
- Alarm, audible
- Failure to Pump
- Repair
Patient
12 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THERE WAS A CONSTANT "AIR SEPARATOR LOW" ALARM ON THE DIALYSIS MACHINE. THE VACUUM PUMP WAS OPERATING ERRATICALLY AND REQUIRED REPLACEMENT.