MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM 1
Received Feb 13, 2009 · Event occurred Jan 8, 2009
Report 1828100-2009-00077 · MDR key 1350652
Device
Generic name
Heart Lung Console (air Bubble Sensor)
Manufacturer
Terumo Cardiovascular Systems CorpModel number
802110Catalog number
802110
Product problems
- Sensor problems
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem
WHEN IN USE, THE AIR BUBBLE DETECTOR OF A HEART LUNG CONSOLE PRODUCED FALSE ALARM. THERE WERE NO REPORTED CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.