SPECTRA OPTIA

Description of Event or Problem

STAFF REPORT: 14 MINUTES AFTER STARTING STEM CELL COLLECTION, THE APHERESIS MACHINE ISSUED A WARNING THEN IMMEDIATELY SWITCHED TO A BLUE DOS SCREEN AND THEN SHUT ITSELF DOWN. I CAME INTO THE ROOM AT THIS POINT AND TRIED TO TROUBLESHOOT. WE TURNED THE MACHINE BACK ON AND GOT A "PROCESSOR FOR SAFETY SYSTEM FAILED TO START CORRECTLY" WARNING. IT SUGGESTED EITHER RESTARTING THE MACHINE OR CALLING THE COMPANY FOR ASSISTANCE. I CALLED THE COMPANY SINCE THE MACHINE HAD JUST RESTARTED AND SHE DIRECTED ME TO RESTART THE MACHINE. IT BROUGHT US TO A SCREEN WHERE WE HAD TO DISCONNECT SO THAT IS WHAT WE DID. MEANWHILE I PULLED THE MACHINE OUT OF SERVICE. WE WERE ABLE TO START OVER ON A NEW MACHINE BUT THE PATIENT NEED TO BE EXPOSED TO A SECOND UNIT OF BLOOD FOR THE BLOOD PRIME AS A RESULT OF THIS MALFUNCTION. MANUFACTURER CAME ON SITE TO EVALUATE THE SYSTEM. SERVICE REPORT STATES: EXAMINED DLOGS AND FOUND 2 INSTANCES OF SAFETY FAILED TO BOOT. REPLACED SAFETY STACK, RJ-45 CABLE AND PERFORMED MOTHER BOARD ALIGNMENT AS PER MFG PROCEDURES.