TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Description of Event or Problem

AS REPORTED, DURING FLUSHING IN THE INTENSIVE CARE UNIT (ICU) AFTER A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THIS DISPOSABLE PRESSURE TRANSDUCER, SALINE LEAKAGE WAS NOTICED AT THE CONNECTION TO THE ARTERIAL CATHETER, PREVENTIVE THE MAINTENANCE OF TUBING'S SEAL. WAVEFORM AND VALUES PROVIDED WERE NOT CORRECT. NO ERROR MESSAGE WAS PROVIDED. NO LOOSE CONNECTIONS OR EXTERNAL COMPRESSION WERE IDENTIFIED. AS PER CUSTOMER'S OPINION, THE ISSUE WAS ASSOCIATED TO A SENSOR SEAL FAILURE. ISSUE WAS SOLVED REPLACING THE DEVICE WITH AN UNIT FROM THE SAME LOT NUMBER. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. 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.