Description of Event or Problem · 1
A MEDWATCH REPORT HAS BEEN RECEIVED FROM FDA. THE FACILITY HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION ON THIS EVENT. IN SPEAKING WITH THE REPORTER OF THE EVENT, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED. THAT THE PATIENT WAS OBSERVED EVERY 15 MINUTES UP UNTIL THE EVENT OCCURRED. REPORTEDLY, THE RN HAD LEFT THE PATIENT'S BEDSIDE TO GET MEDICATIONS AND FOUND THE PATIENT TO BE DISCONNECTED UPON HER RETURN. IT WAS ALSO REPORTED THAT THE PATIENT SUCCESSFULLY RECEIVED 2 HOURS OF DIALYSIS WITH USE OF THESE BLOODLINES PRIOR TO THE EVENT WITH NO REPORT OF ANY DIFFICULTY TO USE. A CATHETER TO BLOODLINE SAFETY DEVICE WAS NOT USED. CURRENTLY, IT HAS BEEN LEARNED THAT THIS PATIENT'S HEALTH STATUS IS IMPROVING AND SHE IS EXPECTED TO BE DISCHARGED. OF NOTE: IT IS CONFIRMED THAT NO DEATH OCCURRED AS WAS INITIALLY REPORTED AND NOTED ON THE MEDWATCH REPORT AND THAT THE EVENT IS A DISCONNECTION. THE REPORTER WAS NOT SURE IF THE NURSE HAD INSPECTED THE LINES OR CONNECTOR AREAS PRIOR TO DISCARDING THEM.