Description of Event or Problem · 1
CELLEX INSTRUMENT 40158 HAD BEEN PRIMED BY ANOTHER NURSE WITH KIT LOT #A313/836 WITH THE FOLLOWING ALARMS: #44 PRIME 11 ALARMS X2, #23 RETURN TEST PRESSURE FAILURE X1, #43 PRIME 10 ALARMS X2; THE PRIMING NURSE CALLED AND CONFERRED WITH THERAKOS BUT ALARMS CLEARED WITHOUT FURTHER DIFFICULTY. THIS NURSE INITIATED ECP USING CELLEX INSTRUMENT VIA PATIENT'S CATHETER IN DOUBLE NEEDLE MODE. ECP PROCEEDED WITHOUT ALARMS OR PATIENT COMPLAINT. HOWEVER, AFTER THE INSTRUMENT HAD COMPLETED "PURGING AIR" PHASE OF TREATMENT, IT DID NOT THEN DISPLAY A "RETURN RATE" ON THE SCREEN. ECP WAS PAUSED. FURTHER INVESTIGATION SHOWED MINIMAL FLUID - 13/14ML IN THE RETURN BAG (MARKED "R"), WHICH WAS HANGING ON THE RIGHT LOAD SENSOR HOOK, AND THE TREATMENT BAG (MARKED "T"), WHICH WAS HANGING ON THE LEFT LOAD SENSOR HOOK, WAS FILLING WITH BLOOD. ALSO, THE FLUID BALANCE WAS BECOMING MORE NEGATIVE, UP TO -377ML. ALSO NOTED THAT THE HEMATOCRIT SENSOR WAS ON THE LINE TO THE BAG MARKED "R" INSTEAD OF THE TREATMENT BAG ("T"), MEANING THAT THE BAGS APPEARED TO BE ON THE WRONG LINES OR MISLABELED. CONTINUED TO PAUSE ECP AND THERAKOS WAS CALLED TO CONSULT. SPOKE TO REP #1, REP RN AND REP #2 OF THERAKOS; WAS DETERMINED KIT WAS DEFECTIVE AND SAFEST COURSE WAS TO ABORT ECP AND MANUALLY RETURN PATIENT'S BLOOD PRODUCTS VIA A GRAVITY BLOOD FILTER SET, THUS PREVENTING EXCESS ACDA ANTICOAGULANT FROM RETURNING TO THE PATIENT. VITAL SIGNS REMAINED STABLE. ATTENDING MD AND NP WERE INFORMED. ECP IS RESCHEDULED TO 2 DAYS FROM NOW. RATIONALE FOR ENDING TREATMENT AND RESCHEDULING WAS EXPLAINED TO PATIENT. KIT WILL BE SENT TO BIOMED, THEN TO THERAKOS FOR EVALUATION. ECP MEDICAL DIRECTOR AND ECP NURSE MANAGER WERE NOTIFIED.