WILLIAM HARVEY OVER PRESSURE SAFETY VALVE

Description of Event or Problem

ON JULY 23, 2009, IT WAS REPORTED BY A USER FACILITY ((B) (4)) TO TERUMO CARDIOVASCULAR THAT DURING A CARDIOPULMONARY BYPASS PROCEDURE, AN OVERPRESSURE RELIEF VALVE MAY HAVE EXHIBITED A CRACK DURING USE. AS A RESULT OF THIS EVENT, THE DEVICE WAS REPLACED AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER INCIDENT. THE USER FACILITY REPORTED THAT THE PT DID NOT SUFFER INJURY OF ANY TYPE AS A RESULT OF THIS EVENT (ALTHOUGH IT IS APPARENT THAT THERE WAS MINIMAL/INSIGNIFICANT BLOOD LOSS).

Additional Manufacturer Narrative

THE USER FACILITY REPORTED THAT THE PRESSURE RELIEF VALVE MAY HAVE EXHIBITED A CRACK DUE TO THE "SPRAY OF BLOOD" THAT WAS OBSERVED IN A VENT LINE DURING A CARDIOPULMONARY BYPASS PROCEDURE. THE USER FACILITY DID NOT MAINTAIN THE DEVICE - AND IMMEDIATELY DISCARDED IT AFTER REMOVING FROM THE CIRCUIT. TERUMO'S INVESTIGATION (INCLUDING INTERVIEWS WITH THE USER FACILITY) REVEALED THAT THE DEVICE MOST LIKELY PERFORMED EXACTLY IT IS INTENDED IN THAT THE POSITIVE PRESSURE UMBRELLA "ACTIVATED" WHEN THERE WAS A PRESSURE INCREASE IN THE CIRCUIT. TERUMO DRAWS THIS CONCLUSION BASED UPON THE "SPRAY" THAT WAS DESCRIBED IN THE COMPLAINT. IF THE DEVICE HAD BEEN DEFECTIVE/CRACKED, THE LIKELY SCENARIO IS THAT FLUID WOULD LEAK FROM THE VALVE AND WOULD NOT HAVE SPRAYED FROM THE VALVE. TERUMO DOES NOT CONSIDER THIS EVENT TO BE THE RESULT OF A DEFECTIVE PRODUCT, BUT RATHER THE RESULT OF ANOTHER EVENT THAT OCCURRED DURING THE OPERATIONAL CONTEXT OF THE SURGERY. THE VALVE APPEARS TO HAVE PERFORMED AS INTENDED.