MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM 1
Received Jan 9, 2008 · Event occurred Dec 10, 2007
Report 1828100-2008-00014 · MDR key 977669
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
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT CONCLUDED.
Description of Event or Problem
DURING PREPARATION FOR USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS, THE AIR BUBBLE SENSOR REPORTEDLY SOUNDED AN ALARM, EVEN THOUGH NO AIR WAS PRESENT IN THE EXTRACORPOREAL TUBING. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.