TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. IT WAS FURTHER INFORMED THAT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED AT HOSPITAL DUE TO INFECTION. WITHOUT RETURN OF THE PRODUCT, EDWARDS IS UNABLE TO PERFORM A COMPLETE INVESTIGATION OF THE REPORTED EVENT. IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO IT, AND THEREFORE NO ACTIONS COULD BE PLANNED.

Description of Event or Problem

AS REPORTED, DURING SET-UP OF THIS DISPOSABLE PRESSURE TRANSDUCER (DPT), THE CARDIAC OUTPUT (CO) VALUE DISPLAYED WAS 1.1 L/MIN WHEREAS THE EXPECTED VALUE ACCORDING TO PATIENT CONDITION WAS 5 L/MIN. NO ERROR MESSAGE WAS DISPLAYED. THE PATIENT WAS NOT TREATED BASED ON INCORRECT VALUES. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS INFECTED.