MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM 1
Received Mar 12, 2008 · Event occurred Feb 1, 2008
Report 1828100-2008-00176 · MDR key 1012800
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems CorpModel 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 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.
Additional Manufacturer Narrative
EVAL IN PROGRESS BUT NOT CONCLUDED.