GAMBRO
Received Mar 13, 2008 · Event occurred Sep 26, 2007
Report 1020404 · MDR key 1020404
Device
Generic name
Hemodialysis Machine
Manufacturer
Gambro Renal Products, Inc.Model number
PHOENIXCatalog number
*
Lot number
*
Product problems
- Output, high
- Incorrect Software Programming Calculations
- Use of Device Problem
Patient
14 YR
- Weight Changes
Narrative
Description of Event or Problem
OPERATOR REPORTED THAT MACHINE DID NOT PULL THE TARGET WEIGHT FROM THE PATIENT. OPERATOR MAY HAVE MADE AN ERROR REGARDING WEIGHT ENTERED DURING THE TREATMENT.