OHMEDA SURGICAL FREE FLOW VACUUM REGULATOR

Description of Event or Problem

THE OHMEDA MEDICAL VACUUM REGULATOR INVOLVED IN THIS REPORT WAS BEING USED AS A COMPONENT OF A HEART STABILIZATION DEVICE MARKETED BY ANOTHER COMPANY AND USED DURING BEATING HEART SURGERY. IT WAS REPORTED THAT A HEART TISSUE INJURY OCCURRED IN THE PROXIMITY OF THE SUCTION APPLICATOR. THE INJURY WAS SURGICALLY REPAIRED AND THE PATIENT HAS SINCE RECOVERED. IT WAS ALSO REPORTED THAT, AT THE TIME OF THE INJURY, THE VACUUM LEVEL PROVIDED BY THE OHMEDA MEDICAL DEVICE INCREASED AFTER AN ACCIDENTAL IMPACT ON THE IV POLE ON WHICH THE DEVICE WAS MOUNTED. OHMEDA MEDICAL OBTAINED THE SUBJECT DEVICE, MANUFACTURED IN 1999, AND WAS ABLE TO CONFIRM THAT THE VACUUM LEVEL COULD BE CHANGED BY IMPACT. INSPECTION OF THE DEVICE REVEALED THAT THE CONTROL KNOB TORQUE WAS NOT SET TO MANFACTURING SPECIFICATIONS OR SERVICE RECOMMENDATIONS, AND THIS CONTRIBUTED TO THE UNINTENDED ROTATION OF THE KNOB UNDER IMPACT CONDITIONS.