MalfunctionKRL
TERUMO ULTRASONIC AIR SENSOR
Received Jun 20, 2006 · Event occurred May 24, 2006
Report 1828100-2006-00237 · MDR key 730680
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Lot number
NA
Product problems
- Sensor problems
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PREPARATION FOR CARDIOPULMONARY BYPASS, THE AIR DETECTION SENSOR CONTINUOUSLY INDIACTED THE PRESENCE OF AIR, EVEN THOUGH NO AIR WAS PRESENT. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
H3: EVALUATION ANTICIPATED BUT NOT YET BEGUN.