MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM 1
Received Jun 17, 2008 · Event occurred May 27, 2008
Report 1828100-2008-00302 · MDR key 1061605
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5791Catalog number
5791
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 DISPLAYED AN AIR DETECT MESSAGE 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.