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 (ADAPT TO CASE). 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. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

Description of Event or Problem

AS REPORTED, DURING PATIENT CARE IN THE CARDIAC SURGERY RESUSCITATION UNIT AFTER THE RADIOGRAPHIC PROCEDURE, THIS PRESSURE MONITORING SET BECAME UNSCREWED AND DETACHED, RESULTING IN SIGNIFICANT BLOOD LEAKAGE (APPROXIMATELY 500 ML), EVIDENCED BY A LARGE POOL OF BLOOD ON THE FLOOR (MANUFACTURER REFERENCE NUMBER (B)(4)). THE ISSUE WAS PROMPTLY DETECTED, THE LINE WAS REPLACED UNDER STERILE CONDITIONS, AND THE RADIOGRAPHERS WERE REMINDED TO EXERCISE INCREASED VIGILANCE WHEN POSITIONING THE PLATES. THIS TYPE OF INCIDENT WAS RECURRENT, AS THE SCREW THREAD OF THE PRESSURE HEADS IS VERY EASY TO LOOSEN, LEADING TO ACCIDENTAL DISCONNECTIONS DESPITE CAREFUL HANDLING (MANUFACTURER REFERENCE NUMBER (B)(4)). THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

Description of Event or Problem

AS REPORTED, DURING CARE OF PATIENTS WITH PRESSURE MONITORING SETS THE SCREW THREAD OF THE PRESSURE HEADS LOOSEN EASILY, LEADING TO ACCIDENTAL DISCONNECTIONS RESULTING IN BLOOD LEAKAGE DESPITE CAREFUL HANDLING. THE ISSUES WAS PROMPTLY DETECTED, THE LINE WAS REPLACED UNDER STERILE CONDITIONS, AND THE RADIOGRAPHERS WERE REMINDED TO EXERCISE INCREASED VIGILANCE WHEN POSITIONING THE PLATES. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

UPDATED SECTION B5, H6 (COMPONENT CODE), H6 (TYPE OF INVESTIGATION), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE REPORTED MALFUNCTION COULD NOT BE CONFIRMED SINCE NO PRODUCT SAMPLES NOR IMAGES WERE PROVIDED FOR EVALUATION, HOWEVER, THERE ARE MANUFACTURING CONTROLS TO RELATED TO THE REPORTED MALFUNCTION.