COPILOT

Description of Event or Problem

IT WAS REPORTED THE COPILOT BLEEDBACK CONTROL VALVE (BBCV) WAS BLOCKED AT THE SCREW THREAD. THIS ISSUE OCCURRED WITH TWO DEVICES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED LOOSE OR INTERMITTENT CONNECTION WAS NOT CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT OF SPECIFIC ISSUE. AS THE REPORTED LOOSE OR INTERMITTENT CONNECTION WAS UNABLE TO BE CONFIRMED DURING THE RETURN ANALYSIS, IT IS POSSIBLE THAT THE DEVICES WERE NOT PROPERLY ALIGNED AND/OR NOT FULLY CONNECTED/TIGHTENED WHILE ATTEMPTING TO CONNECT, AND/OR THE PORT OF THE DEVICE BEING CONNECTED WAS COMPROMISED, RESULTING IN THE REPORTED LOOSE/INTERMITTENT CONNECTION; HOWEVER, THIS CANNOT BE CONFIRMED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

Description of Event or Problem

IT WAS REPORTED THE COPILOT BLEEDBACK CONTROL VALVE (BBCV) WAS BLOCKED AT THE SCREW THREAD. THIS ISSUE OCCURRED WITH TWO DEVICES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.