MalfunctionKRL
TERUMO ULTRASONIC AIR SENSOR
Received Aug 26, 2006 · Event occurred Jul 28, 2006
Report 1828100-2006-00333 · MDR key 777039
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Lot number
NA
Product problems
- Program, failure to
- Sensor problems
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PREPARATION FOR OR DURING CARIOPULMONARY BYPASS, THE AIR DETECTION SENSOR COULD NOT BE RESET. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS BUT NO CONCLUSION REACHED.