DeathKRL
SHILEY HEART LUNG MACHINE
Received Aug 8, 1996 · Event occurred Jul 11, 1996
Report 36759 · MDR key 36759
Device
Generic name
Bubble Detector
Manufacturer
Sorin Biomedical, Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Device Alarm System
- Leak/Splash
Patient
87 YR
- Air Embolism
- Death
Narrative
Description of Event or Problem
AIR OBSERVED IN ARTERIAL LINE AT FIELD, DURING OPEN HEART SURGERY WITH PROBABLE AIR INADVERTENTLY INJECTED OR PUMPED INTO THE AORTA.