TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

IT WAS FURTHER INFORMED THAT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED AT HOSPITAL. 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. 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.

Description of Event or Problem

AS REPORTED, UPON INSPECTION DUE TO THE PRESENCE OF LARGE BLOOD CLOTS OBSERVED IN THE PRESSURE LINE, THIS SINGLE DISPOSABLE PRESSURE TRANSDUCER (DPT) WITH VAMP PLUS WAS FOUND TO BE LEAKING THROUGH THE TOP OF THE DRIP CHAMBER. THEREFORE NO GOOD ARTERIAL LINE TRACE WAS PROVIDED (MANUFACTURER REFERENCE (B)(4)). TERRITORY MANAGER CONFIRMED THIS EVENT WAS NOT ATTRIBUTED TO USE ERROR, AND SALINE BAG HAD BEEN PRESSURIZED TO 300 MHG ACCORDING TO THE IFU. AS PER CUSTOMER OPINION, THERE MAY HAVE BEEN AIR INGRESS INTO THE SYSTEM AS WELL. THE DEVICE WAS REPLACED BY A NEW ONE FROM THE SAME LOT NUMBER, BUT THE SAME ISSUE OCCURRED (MANUFACTURER REFERENCE (B)(4)). THERE WAS NO ALLEGATION OF PATIENT INJURY. ONLY THE DEVICE INVOLVED IN THE EVENT REGISTERED UNDER MANUFACTURER REFERENCE (B)(4) WAS AVAILABLE FOR EVALUATION, SINCE THE OTHER ONE WAS DISCARDED; HOWEVER, IT HAS NOT BEEN RECEIVED YET. AS A SUMMARY, TWO INITIAL REPORTS ARE BEING SUBMITTED (MANUFACTURER REFERENCES (B)(4)).