MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM 1
Received Jan 19, 2008 · Event occurred Dec 10, 2007
Report 1828100-2008-00041 · MDR key 989988
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Product problems
- Sensor problems
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS, THE AIR BUBBLE SENSOR FAILED TWICE. THE NATURE OF THE FAILURE WAS NOT REPORTED. WHEN THE DEVICE WAS POWER-CYCLED, IT COULD NOT BE ACTIVATED FOR USE. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT CONCLUDED.