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Patient 1
THE COMPLAINT SAMPLE WAS NOT AVAILABLE; HOWEVER, THE CUSTOMER PROVIDED A PICTURE OF THE BAG. THE PICTURE INDICATED A FILM BREAKAGE UNDER ONE OF THE TWO SPIKE PORT COMPONENTS AT THE TOP OF THE BAG. THE FILM BREAKAGE APPEARED TO EXTEND ACROSS THE WIDTH OF THE SPIKE PORT COMPONENT BASE. SINCE THE LEAK WAS REPORTED DURING THE THAWING PROCESS, THE PRESUMPTION IS MADE THAT THE FILM BREAKAGE DID NOT EXIST DURING FILLING OR PRIOR TO FREEZING. THERE ARE 2 POSSIBLE CAUSES FOR A FAILURE MODE OF THIS NATURE: MANUAL EQUIPMENT RESET. A CAPA INVESTIGATION IDENTIFIED A MANUAL EQUIPMENT RESET PROCESS ON THE EQUIPMENT USED TO PRODUCE THE CF-250 BAGS. THE EQUIPMENT IS MANUALLY RESET BETWEEN WELDING CYCLES. IF NOT FULLY RESET, INTERMITTENT FILM STRESS COULD OCCUR AT THE PORT/FILM INTERFACE. FILM STRESS AT THE PORT/FILM INTERFACE COULD WEAKEN THE FILM AND POTENTIALLY CONTRIBUTE TO FILM BREAKAGE DURING CRYOGENIC FREEZING OR THAWING CONDITIONS. USER HANDLING: USER HANDLING OF THE DEVICE BY THE PORT TUBES WHILE THE BAG IS IN A FROZEN STATE. THERE ARE SEVERAL POSSIBLE CONDITIONS WHICH COULD CONTRIBUTE TO HANDLING DAMAGE: RESIDUAL MOISTURE ON THE OUTSIDE OF THE BAG WHEN IT WAS PLACED INSIDE THE CASSETTE. RESIDUAL MOISTURE COULD CAUSE THE BAG TO FREEZE/ADHERE TO THE CASSETTE DURING THE FREEZING PROCESS. A CONDITION OF THIS TYPE COULD CAUSE FILM DAMAGE UPON REMOVAL OF A FROZEN BAG FROM THE CASSETTE. HANDLING OF THE BAG IN THE FROZEN STATE. THE FILM OF A FROZEN BAG IS FRAGILE - INADVERTENT MANIPULATION OR IMPACT ON THE BAG COULD CAUSE THE FILM TO FRACTURE. THE PRECAUTIONS INDICATED ABOVE ARE ADDRESSED IN THE PRODUCT IFU'S.