TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

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 AN INVESTIGATION WILL BE COMPLETED TO CONSIDER ANY POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND 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.

Description of Event or Problem

AS REPORTED, DURING USE IN PATIENT FOR EXTRACORPOREAL CANNULATION, THIS DISPOSABLE PRESSURE TRANSDUCER (DPT) DID NOT READ PROPERLY THE ARTERIAL BLOOD PRESSURE (BP). IN ADDITION, WHEN ATTEMPTING TO FLUSH THE LINE, THE SNAP-TAB BROKE. TO SOLVE THE ISSUE, THE DEVICE WAS REPLACED. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.