SPECTRA OPTIA

Description of Event or Problem

PLASMAPHERESIS STARTED. RBC DETECTOR ALARMED AND HEMOLYSIS NOTED IN THE COLLECTION TUBING. TERUMO WAS CONTACTED AND AFTER MANY ATTEMPTS TO CORRECT BY INCREASING THE HEMATOCRIT VALUE AND REDUCING THE INLET FLOW RATE WITHOUT RESOLVING THE PROBLEM, THE STAFF PERFORMED RINSE-BACK, THEN PRIMED AND LOADED NEW TUBING. THIS RESOLVED THE ISSUE.THE PATIENT DID NOT SUFFER ANY ILL EFFECTS.====================== MANUFACTURER RESPONSE FOR PLASMAPHERESIS MACHINE AND TUBING, SPECTRA OPTIA (PER SITE REPORTER).====================== THE TUBING WAS RETURNED TO THE MANUFACTURER.THE SET WAS INSPECTED FOR MISSING PARTS, MIS-ASSEMBLIES, KINKS AND OCCLUSIONS. NONE WERE FOUND. BASED ON THE DESCRIPTION OF THE ISSUE AND THE EVALUATION OF THE SET, THE ROOT CAUSE FOR THIS ALARM WAS AN RBC SPILL-OVER, LIKELY CAUSED BY THE USE OF THE PREVIOUS DAYS HEMATOCRIT. ENSURING THE MOST CURRENT AND ACCURATE PATIENT INFORMATION AVAILABLE IS ENTERED INTO THE SPECTRA OPTIA MACHINE AS EARLY AS POSSIBLE IN THE PROCEDURE IS KEY TO THE SYSTEM PERFORMANCE. NO CORRECTION WS PERFORMED FOR THIS INCIDENT BY TERUMO BCT. TRENDS ARE REGULARLY MONITORED TO DETERMINE APPROPRIATE CORRECTIVE ACTIONS BY MANUFACTURING OR ENGINEERING.