THE INTERNATIONAL DISTRIBUTOR ((B)(6)) REPORTED AN ISSUE ENCOUNTERED BY THEIR CUSTOMER WHILE USING THE SUCTION CONTROL VALVE. THIS VALVE IS PROVIDED BY THE MANUFACTURER AS AN OEM DEVICE TO THE DISTRIBUTOR FOR FURTHER PROCESSING/STERILIZATION. THE REPORTED STATED THAT THE PERFUSIONIST OBSERVED THE VALVE LEAKING DURING A PROCEDURE. THERE WAS NO PATIENT INFORMATION PROVIDED. THE DISTRIBUTOR PROVIDED A VIDEO FROM THE CUSTOMER WHICH SHOWED VERY SLIGHT LEAKAGE BUT NO ACTUAL BLOOD DROPS FROM THE VALVE DURING USE. THERE WERE NO ACTIONS TAKEN DURING THE PROCEDURE AS A RESULT OF THE ALLEGED EVENT. THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT RETURNED TO THE DISTRIBUTOR OR MANUFACTURER FOR ANALYSIS. THE DISTRIBUTOR AND THE CUSTOMER WERE NOT SURE OF THE LOT NUMBER OF THE IMPLICATED PRODUCT BUT THEY KNOW IT WAS ONE OF 3 POSSIBLE LOT NUMBERS. THEREFORE 3 MDRS ARE BEING SUBMITTED TO DOCUMENT THOSE LOT NUMBERS. SEE ALSO 1649914-2015-00045 AND 1649914-2015-00051. NONE OF THOSE LOTS REMAINS IN THE MANUFACTURER'S INVENTORY FOR ANALYSIS.
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Patient 1
THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION. THE PURPOSE OF THE VALVE IS TO PREVENT EXCESSIVE NEGATIVE PRESSURE IN THE VENTRICLE. IT CONTAINS AN ANTI-BACKFLOW FEATURE TO PREVENT RETROGRADE FLOW AND A PRESSURE RELIEF VALVE THAT BENTS BLOOD IN THE EVENT OF RETRODGRADE FLOW DUE TO OPERATOR OR INSTALLATION ERROR. THERE IS AN OPEN CPAR 15--2 TO ADDRESS ALLEGED LEAKING VALVE DEFECTS DUE TO UMBRELLA VALVE ISSUES. QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.