MalfunctionFII
PHOENIX
Received Jul 1, 2009 · Event occurred Jun 1, 2009
Report 1414156 · MDR key 1414156
Device
Generic name
Hemodialysis Machine
Manufacturer
Gambro Renal Products, IncModel number
*Catalog number
*
Lot number
*
Product problems
- Leak/Splash
- Loss of Power
Patient
16 YR
- No Information
Narrative
Description of Event or Problem
MACHINE SUDDENLY STOPPED DURING A TREATMENT. MACHINE HAD A GENERAL SAFE STATE ALARM THAT ATTRIBUTED TO FAILURE OF THE PI/PO FAILURE OF THE T1 TEST. THE CAUSE OF THE FAILURE WAS TRACED TO A LEAK PRESENT IN THE PUF PERISTALTIC PUMP SEGMENT FAILURE. CHANGED THE PUMP SEGMENT AND T1 TEST PASSED FOUR CONSECUTIVE TIMES.