SHUNT SENSOR SYS500

Description of Event or Problem

THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEM 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 EVAL OF THE DEVICE, THE COMPLAINT WAS CONFIRMED. THE UNIT WAS PERFORMANCE TESTED, AND THE BEHAVIOR OF THE UNIT WAS INDICATIVE OF A LEAK. VISUAL INSPECTION OF THE UNIT FOUND THAT THE DOME WAS MISSING FROM THE PH CHEMISTRY POSITION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED, AS THE LOT NUMBER IS UNK. THE MOST PROBABLE CAUSE OF THE LEAK IS THAT THIS PARTICULAR UNIT WAS ON THE LOWER SIDE OF THE ADHESIVE INJECTION VOLUME FOR THE PRIMARY ADHESIVE RING. THIS UNIT WAS SUFFICIENTLY CURED AND SEALED TO PASS THROUGH OUR 100% LEAK TEST, BUT NOT ENOUGH TO SURVIVE SHIPPING, HANDLING, AND TEMPERATURE/PRESSURE CHANGES. THE MOST PROBABLE REASON FOR THE DOME DETACHMENT IS FROM SHEAR STRESS INFLICTED BY A POINTED OBJECT THAT LEFT MARKS ON THE POLYCARBONATE. (B)(4). ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.