MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM 1
Received Apr 21, 2008 · Event occurred Mar 25, 2008
Report 1828100-2008-00218 · MDR key 1032169
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 PREPARATION FOR USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS, THE AIR BUBBLE SENSOR CONTINUOUSLY ALARMED AND COULD NOT BE RESET. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVAL IN PROGRESS BUT NOT CONCLUDED.