SHUNT SENSOR SYS500

Description of Event or Problem

THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS SURGERY THE SHUNT SENSOR LEAKED. LESS THAN 1CC BLOOD LOSS. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFUL.

Additional Manufacturer Narrative

UPON EVALUATION OF THE DEVICE THE COMPLAINT WAS CONFIRMED. THE UNIT WAS VISUALLY INSPECTED AND PRESSURIZED, AND A LEAK WAS OBSERVED AT THE THERMOWELL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. THIS UNIT WAS SUFFICIENTLY CURED AND SEALED TO PASS THROUGH A 100 PERCENT LEAK TEST. THE ROOT CAUSE, A LEAK FROM THE THERMOWELL POSITION RESULTING FROM STRESS, WAS IDENTIFIED TO BE SHIPPING AND HANDLING PAIRED WITH THE COUPLING OF THE SENSOR TO THE BPM HEAD. (B)(4). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.