MalfunctionFII
PHOENIX
Received Jun 12, 2009 · Event occurred Nov 25, 2008
Report 1405887 · MDR key 1405887
Device
Generic name
Hemodialysis Machine
Manufacturer
Gambro Renal Products, Inc.Model number
PHOENIXCatalog number
*
Lot number
*
Product problems
- Corroded
- Leak/Splash
Patient
13 YR
- No Information
Narrative
Description of Event or Problem
BICARBONATE LEAKING FROM THE BICART ARM CAUSED THE J37 CONNECTOR ON THE POWER SUPPLY TO BECOME CORRODED, WHICH RESULTED IN A GENERAL SAFE STATE ALARM AND AN AUTOMATIC SHUT DOWN OF THE DIALYSIS MACHINE.
Description of Event or Problem
BICARBONATE LEAKING FROM THE BICART ARM CAUSED THE J37 CONNECTOR ON THE POWER SUPPLY TO BECOME CORRODED, WHICH RESULTED IN A GENERAL SAFE STATE ALARM AND AN AUTOMATIC SHUT DOWN OF THE DIALYSIS MACHINE.