MalfunctionKRL
TERUMO AIR BUBBLE DETECTOR
Received Jul 17, 2007 · Event occurred Jun 18, 2007
Report 1828100-2007-00206 · MDR key 882097
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
Additional Manufacturer Narrative
EVALUATION ANTICIPATED BUT NOT BEGUN.
Description of Event or Problem
DURING PREPARATION FOR USE FOR CARDIOPULMONARY BYPASS, THE AIR BUBBLE SENSOR ISSUED A FALSE AIR BUBBLE ALARM AND COULD NOT BE RESET. THERE WAS NO ADVERSE CONSEQUENCE TO A PATIENT AS A RESULT OF THIS EVENT.