MalfunctionKRL
TERUMO ULTRASONIC AIR SENSOR
Received Jun 29, 2006 · Event occurred May 30, 2006
Report 1828100-2006-00242 · MDR key 736354
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Lot number
NA
Product problems
- False Alarm
- Sensor problems
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PREPARATION FOR CARDIOPULMONARY BYPASS, THE AIR DETECTION SENSOR CONTINUOUSLY INDICATED THE PRESENCE OF AIR, EVEN THOUGH, NO AIR WAS PRESENT. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
ACTUAL DEVICE INVOLVED IN EVENT WAS EVALAUTED, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, NEGATIVE RESULTS OF DEVICE TESTING, DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, NO FAILURE DETECTED AND DEVICE WITHIN SPECIFICATION.