MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM 1
Received Dec 26, 2007 · Event occurred Nov 28, 2007
Report 1828100-2007-00485 · MDR key 971594
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5785Catalog number
5785
Product problems
- Sensor problems
Patient
YR
- 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 PATIENT AS A RESULT OF THIS EVENT.