MalfunctionKRL
TERUMO PERFUSION SYSTEM 8000
Received Jun 17, 2008 · Event occurred May 23, 2008
Report 1828100-2008-00326 · MDR key 1061606
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
EVAL IN PROGRESS, BUT NOT CONCLUDED.
Description of Event or Problem
DURING USE FOR CARDIOPULMONARY BYPASS SURGERY, THE AIR BUBBLE DETECTION SYSTEM REPEATEDLY ALARMED EVEN THOUGH AIR WAS NOT PRESENT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT AS A RESULT OF THIS EVENT.