TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

THE DEVICE INVOLVED IN THIS CASE WAS NOT AVAILABLE FOR EVALUATION. NEVERTHELESS, IMAGERY WAS PROVIDED FOR INVESTIGATION. BASED ON THE REVIEW, CUSTOMER REPORT OF PRESSURE TUBING ISSUE WAS CONFIRMED BUT IT WAS DETACHED RATHER THAN BROKEN. IMAGE SHOWED A CLOSE UP ON A MALE CONNECTOR OF A PRESSURE LINE. THE MALE CONNECTOR WAS NOTICED COMPLETELY DETACHED FROM PRESSURE TUBING. WHAT APPEARED TO BE BLOOD WAS EVIDENT INSIDE PRESSURE LINE. NO OTHER VISIBLE INCONSISTENCIES WAS NOTICED FROM IMAGE PROVIDED. FURTHER INVESTIGATION WAS COMPLETED BY THE ENGINEERS IN THE MANUFACTURING SITE. BASED ON THIS ASSESSMENT, IT COULD BE DETERMINED THAT THE ROOT CAUSE OF THIS FAILURE WAS RELATED TO AN INTERNAL COMPONENT FAILURE. THE MANUFACTURING RECORDS WERE REVIEWED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE; ALL PROCESS PARAMETERS WERE MET, AND INSPECTIONS PASSED SUCCESSFULLY. BASED ON THE AVAILABLE INFORMATION, NO ACTION WAS REQUIRED AT THIS TIME; HOWEVER, 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, DURING USE IN PATIENT, THIS DISPOSABLE PRESSURE TRANSDUCER TUBING BROKE, CAUSING MINIMAL BLEEDING FROM THE ARTERY. THIS CAUSED A DISRUPTION IN THE PROCEDURE; THE DEVICE WAS REPLACED WITH A NEW UNIT AND THE ISSUE WAS SOLVED. AS PER CUSTOMER OPINION, THE FAILURE APPEARED TO BE RELATED TO MATERIAL FATIGUE OR A MANUFACTURING DEFECT. THERE WAS NO ALLEGATION OF PATIENT INJURY. AS PER IMAGE EVALUATION, PRESSURE TUBING WAS DETACHED RATHER BROKEN. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.