MalfunctionKRL

TERUMO ADVANCED PERFUSION SYSTEM 1

Received Dec 15, 2007 · Event occurred Nov 16, 2007

Report 1828100-2007-00472 · MDR key 965557

Device

Generic name

Air Bubble Detector

Manufacturer

Terumo Cardiovascular Systems Corp.

Model number

5773

Catalog number

5773

Product problems

Sensor problems

Patient

No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

EVAL IN PROGRESS BUT NOT CONCLUDED.

Description of Event or Problem

DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS, THE AIR BUBBLE SENSOR STOPPED FUNCTIONING. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.