Description of Event or Problem · 1
AFTER A PREPARATION OF A 500ML BAG WAS FINISHED (PREP ID (B)(4)), THE OPERATOR PROCEEDED TO UNLOAD IT. SHE COMPLAINED BECAUSE SHE ENDED UP WITH TWO DIFFERENT BAGS WITH THE SAME LABEL, ONE PUNCTURED 500ML BAG AND ONE NON-PUNCTURED 100ML BAG BOTH WITH THE LABEL OF THE 500ML BAG. AN ANALYSIS OF THE LOGS SHOWED THAT A 100ML BAG WAS NEVER LOADED, THEREFORE, SINCE THE OPERATOR UNLOADED A 100ML BAG, THE CONCLUSION IS THAT THERE WAS A USER ERROR IN LOADING THE BAG. IT WAS CONCLUDED THAT THE OPERATOR, WHILE UNLOADING THE 500ML BAG, WHICH WAS CORRECTLY LABELED, LOADED A 100ML BAG INCORRECTLY. AT THAT POINT, THE DEVICE COULD NOT HAVE KNOWN THAT THE 500ML BAG HAD BEEN UNLOADED. WHEN THE BAG IN THAT POSITION WAS REQUESTED TO BE UNLOADED, THE BAG INSIDE THE DEVICE, AT THAT POINT, WAS A 100ML BAG. UPON UNLOADING, IT WAS LABELED AS IF IT WERE THE 500ML BAG. THE OPERATOR DID NOT FOLLOW THE CORRECT LOADING PROCESS CAUSING THE EVENT DESCRIBED ABOVE.