PRESSURE MONITORING SET

Description of Event or Problem

AS REPORTED, DURING USE OF THIS PRESSURE MONITORING KIT ON PATIENT, THE PRESSURE WAVEFORM STOPPED BEING DISPLAYED AND BECAME UNABLE TO PERFORM THE PRESSURE MEASUREMENT AT THE SAME TIME. IN ADDITION, WHEN ATTEMPTING TO CONNECT THE SYRINGE INCLUDED IN THE SAME PACKAGE OF THIS PRESSURE MONITORING KIT TO THE THREE-WAY STOPCOCK LOCATED NEXT TO THE PLANECTA, THE CONNECTOR COULD NOT BE SECURELY TIGHTENED, AS IT ROTATED WITHOUT FIXATION. ALTHOUGH IT COULD NOT BE DETERMINED WHETHER THIS LOOSE CONNECTION WAS THE CAUSE, AIR WAS FREQUENTLY OBSERVED IN THE LINE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. 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 A PART OF THE MONTHLY REVIEW.