MalfunctionFII
GAMBRO
Received Mar 13, 2008 · Event occurred Aug 16, 2007
Report 1018455 · MDR key 1018455
Device
Generic name
Hemodialysis Machine
Manufacturer
Gambro Renal Products, Inc.Model number
PHOENIXCatalog number
*
Lot number
*
Product problems
- Replace
- Overfill
- Device Displays Incorrect Message
Patient
20 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THREE PROBLEMS AT THE BEGINNING OF THE DIALYSIS TREATMENT: HIGH LEVEL IN UF VESSEL, # 144 FLOW BALANCE ERROR AND #145 UF RATE VESSEL. TREATMENT WAS STOPPED AND REINITIATED ON ANOTHER MACHINE. NO HARM TO PATIENT.