inforMED
MalfunctionKRL

TERUMO AIR BUBBLE DETECTOR

Received Jul 14, 2007 · Event occurred Jun 14, 2007

Report 1828100-2007-00203 · MDR key 880943

Device

Generic name

Air Sensor

Model number

5773

Catalog number

5773

Product problems

  • Sensor problems

Patient

YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

DURING PREPARATION FOR USE FOR CARDIOPULMONARY BYPASS, THE AIR BUBBLE SENSOR ISSUED A FALSE AIR BUBBLE ALARM. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

EVALUATION IN PROGRESS BUT NOT CONCLUDED.