SPECTRA OPTIA®

Description of Event or Problem

PT AT INFUSION CENTER FOR PLASMA EXCHANGE. THE FOLLOWING ALARMS OCCURRED ON THE OPTIA APHERESIS MACHINE DURING THE PROCEDURE. "LOW-LEVEL RESERVOIR DETECTED EXCESS FLUID" AND "PATIENT FLUID BALANCE MAY BE 5% HIGHER THAN REPORTED" SCREEN PROMPTS AND TROUBLESHOOTING WAS FOLLOWED AND PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE LOW-LEVEL RESERVOIR ALARMS OCCURRED MORE THAN ONCE. NO PROBLEMS WERE SEEN WITH THE TUBING SET/FLUIDS OR PATIENT LINES. THESE SAME 2 ALARMS HAD ALSO OCCURRED ON A DIFFERENT PATIENT PLASMA EXCHANGE PROCEDURE THE DAY PRIOR WITH THE 2ND OPTIA MACHINE FOR WHICH THE SAME LOT# OF EXCHANGE SET WAS USED. EXCHANGE SET LOT#2310233141. TERUMO BCT WAS CALLED TO REPORT THE ALARMS. MANUFACTURER REPORTED THERE HAVE BEEN OTHER CALLS FOR THE SAME ALARMS. DETERMINED THE CAUSE WAS LIKELY THE EXCHANGE SET/TUBING. THE 9 REMAINING SETS FROM THIS LOT# WERE REMOVED FROM USE. EMAIL REQUEST SUBMITTED TO TERUMO BCT FOR CREDIT OR REPLACEMENT OF SETS. MANUFACTURER RESPONSE FOR TERUMO BCT EXCHANGE SET, (BRAND NOT PROVIDED) (PER SITE REPORTER). MANUFACTURER REPORTED THERE HAVE BEEN OTHER CALLS FOR THE SAME ALARMS. DETERMINED THE CAUSE WAS LIKELY THE EXCHANGE SET/TUBING. THE 9 REMAINING SETS FROM THIS LOT# WERE REMOVED FROM USE. EMAIL REQUEST SUBMITTED TO TERUMO BCT FOR CREDIT OR REPLACEMENT OF SETS.