TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. 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, THE PRESSURE TUBING OF THIS PRESSURE MONITORING SET WITH VAMP SYSTEM WAS BROKEN AND SEPARATED. APPROXIMATELY 50ML OF BLOOD LEAKED FROM PATIENT'S LEFT FEMORAL ARTERY SITE. NURSING STAFF INITIALLY THOUGHT THE TUBING HAD BECOME UNSCREWED FROM THE PORT OR THE ARTERIAL LINE HAD BECOME DISLODGED. THE ARTERIAL LINE HAD TO BE REMOVED. NO ADDITIONAL INTERVENTION WAS REQUIRED. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

Additional Manufacturer Narrative

UPDATED SECTION H6 (COMPONENT CODE), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). IT WAS FURTHER INFORMED THAT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED AT HOSPITAL. WITHOUT RETURN OF THE PRODUCT, IT 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. IT WAS VERIFIED THAT MANUFACTURING CONTROLS ARE IN PLACE TO DETECT ISSUES RELATED TO THE REPORTED MALFUNCTION.