PRESEP CENTRAL VENOUS OXIMETRY KIT

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE RETURNED FOR EVALUATION HOWEVER A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. 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.

Description of Event or Problem

IT WAS REPORTED THAT AFTER REMOVAL OF THE OXIMETRY CATHETER IT WAS FOUND TO HAVE CLOTTED BLOOD. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS DISCARDED AT THE HOSPITAL.