MalfunctionKRL
TERUMO AIR BUBBLE DETECTOR
Received Jul 6, 2007 · Event occurred May 15, 2007
Report 1828100-2007-00186 · MDR key 876690
Device
Generic name
Air Sensor
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Product problems
- Sensor problems
Patient
YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING CARDIOPULMONARY BYPASS, THE AIR BUBBLE SENSOR ISSUED A FALSE AIR BUBBLE ALARM. THE AIR BUBBLE DETECTOR WAS REPLACED AND THE PROCEDURE COMPLETED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT CONCLUDED.