MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM 1
Received Mar 1, 2008 · Event occurred Jan 31, 2008
Report 1828100-2008-00124 · MDR key 1008430
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Product problems
- Sensor problems
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT CONCLUDED.
Description of Event or Problem
DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS, THE AIR BUBBLE SENSOR GAVE AN AIR BUBBLE ALARM, EVEN THOUGH NO AIR WAS PRESENT. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.
Remedial action
- Recall