SPECTRA OPTIA

Description of Event or Problem

S [SITUATION]: SPECTRA OPTIA EXPERIENCED AN AUTOMATED INTERFACE MANAGEMENT (AIM) SYSTEM MALFUNCTION DURING LOADING AND PRIMING OF THE TUBING SET FOR A SCHEDULED PROCEDURE. B [BACKGROUND]: DURING TUBING SETUP, THE SPECTRA OPTIA AUTOMATICALLY TEST AND PRIMES THE TUBING SET. WHILE PREPARING THE THERAPEUTIC EXCHANGE KIT, THE AIM SYSTEM MALFUNCTIONED DURING THE SETUP PROCESS. A [ASSESSMENT]: DURING TUBING SETUP, THE OPTIA ALARMED INDICATING "WRONG FILLER USED FOR PROCEDURE TYPE." THE FILLER WAS CHANGED: HOWEVER, THE SAME ALARM REPEATED. THE RN WAS ABLE TO CONTINUE PRIMING THE TUBING SET, BUT THE OPTIA ALARMED AGAIN INDICATING AN AIM SYSTEM MALFUNCTION. TERUMOBCT WAS CONTACTED, AND A TECHNICIAN RESPONDED ON THREE SEPARATE OCCASIONS WITHOUT RESOLUTION. PER THE TECHNICIAN, THE ISSUE HAS BEEN ESCALATED TO TERMOBCT'S ENGINEERING DEPARTMENT. THE MACHINE WAS TAKEN OUT OF SERVICE AND REMAINS OUT OF SERVICE. R [RECOMMENDATION]: MAINTAIN THE SPECTRA OPTIA DEVICE OUT OF CLINICAL SERVICE UNTIL THE AIM SYSTEM MALFUNCTION IS FULLY RESOLVED. UTILIZE AN ALTERNATIVE OPTIA DEVICE FOR PATIENT PROCEDURES AND OBTAIN DOCUMENTED RESOLUTION AND CLEARANCE FROM TERUMOBCT ENGINEERING PRIOR TO RETURNING THE DEVICE TO SERVICE. MANUFACTURER RESPONSE FOR APHERESIS, CELL COLLECTION, CELL PROCESSING SYSTEM, SPECTRA OPTIA EXPERIENCED AN AUTOMATED INTERFACE MANAGEMENT (AIM) SYSTEM (PER SITE REPORTER).