OtherJOD
SORINGROUP
Received Apr 2, 2012 · Event occurred Mar 28, 2012
Report 2518155 · MDR key 2518155
Device
Generic name
Va Relief Check Val
Manufacturer
Sorin Group UsaCatalog number
029395000
Lot number
1200300126
Product problems
- Fluid/Blood Leak
- Increase in Pressure
Patient
43 YR
- No Information
Narrative
Description of Event or Problem
OVERPRESSURE VALVE ON HEART/LUNG MACHINE BEGAN LEAKING DURING BYPASS RUN. SUCTION LINE STOPPED MOMENTARILY TO REPLACE VALVE. UNK FLUID LOSS DURING LEAK.