MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM 1
Received Feb 23, 2008 · Event occurred Jan 25, 2008
Report 1828100-2008-00109 · MDR key 1005936
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 DETECTION SYSTEM REPEATEDLY ALARMED EVEN THOUGH AIR WAS NOT PRESENT. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT CONCLUDED.