MalfunctionKRL
TERUMO AIR BUBBLE DETECTOR
Received Jan 12, 2008 · Event occurred Dec 13, 2007
Report 1828100-2008-00031 · MDR key 979132
Device
Generic name
Air Sensor
Manufacturer
Terumo Cardiovascular Systems Corp.Model 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 FOR CARDIOPULMONARY BYPASS, THE AIR BUBBLE SENSOR ISSUED A FALSE AIR BUBBLE ALARM. THERE WAS NO ADVERSE CONSEQUENCE TO A PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT CONCLUDED.
Remedial action
- Replace