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. 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.

Description of Event or Problem

AS REPORTED, DURING USE IN A PEDIATRIC PATIENT WITH THIS PRESSURE MONITORING SET THE CONNECTIONS COULD NOT BE TIGHTENED AND THEREFORE THERE WAS A LEAKAGE FROM THE HEPARIN INFUSION FOR THE PATIENT'S ARTERIAL LINE. PREVIOUSLY, WHEN THE REPORTER ENTERED THE ROOM WITH THE RENAL REPLACEMENT THERAPY (RRT) TEAM AND THEIR STUDENT FOR AN OVERNIGHT ASSESSMENT, THE RRT NURSE NOTICED EXCESS FLUID ON THE FLOOR, WHICH APPEARED TO BE FROM THE HEPARIN INFUSION INTO THE PATIENT'S ARTERIAL LINE, WHICH HAD BEEN CHANGED EARLIER IN THE SHIFT. THE SOURCE OF THE LEAK COULD NOT BE DETERMINED, AS ALL CONNECTIONS WERE CONNECTED AND MANUALLY TIGHTENED. THE REPORTER CALLED FOR ANOTHER NURSE TO ASSIST. A SECOND NURSE NOTICED THAT THE TRANSDUCER APPEARED TO BE MOVING AND STATED THAT THIS WAS NOT NORMAL, TO THE BEST OF HER KNOWLEDGE. THE ARTERIAL CATHETER REMAINED PATENT, BUT A NEW ART LINE SET WAS PRIMED AND CONNECTED TO THE EXISTING ARTERIAL CATHETER AND A NEW HEPARIN BAG WAS INSERTED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

Additional Manufacturer Narrative

AS PER FURTHER FOLLOW-UP IT WAS CLARIFIED THAT THE LEAKAGE WAS HEPARINIZED SALINE SOLUTION RATHER THAN HEPARIN. LEAKAGE IMPLIES A SMALL AMOUNT OF BODILY FLUID OR FLUSHING SOLUTION LOSS THAT IS UNLIKELY TO RESULT IN AN INJURY. IF REQUIRED, THE DEVICE CAN BE EXCHANGED WITHOUT AN INCREASE IN THE INHERENT RISK FOR INFECTION AND WITH MINIMAL DELAY IN MONITORING. AS SUCH, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND A CORRECTED SUPPLEMENTAL REPORT IS BEING SUBMITTED.