MalfunctionKRL
TERUMO ULTRASONIC AIR SENSOR
Received Sep 22, 2005 · Event occurred Aug 24, 2005
Report 1828100-2005-00085 · MDR key 650944
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Lot number
*
Product problems
- Alarm, audible
- Bubble(s)
- Replace
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
WHILE SETTING UP THE HEART-LUNG CONSOLE FOR SURGICAL PROCEDURE, LEVEL DETECTOR AND AIR BUBBLE DETECTOR ALARMS WERE OBSERVED UNEXPECTEDLY. THE DEVICE WAS REPLACED PRIOR TO THE PROCEDURE AND THE SURGERY WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THIS EVENT.