MalfunctionKRL
TERUMO ULTRASONIC AIR SENSOR
Received May 8, 2006 · Event occurred Apr 13, 2006
Report 1828100-2006-00191 · MDR key 710206
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Lot number
NA
Product problems
- Sensor problems
Patient
*
Narrative
Description of Event or Problem
DURING PREPARATION FOR AND DURING CARDIOPULMONARY BYPASS, THE AIR DETECTION SENSOR COULD NOT BE RESET, REQUIRING IT TO BE REMOVED FROM SERVICE. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.