MDR report 299038

GENERAL REPORT RECEIVED OF PUMPS CHANGING PROGRAMMING OPTIONS SCREEN FROM "MCG AND MG" TO "DRUGS ONLY" ON ITS OWN. THE CUSTOMER CONTACT FEELS THAT IF THE NURSES ARE "NOT PAYING CLOSE ATTENTION" WHEN PROGRAMMING THE DEVICE, THAT THEY MAY POTENTIALLY SET UP PROGRAMMING WRONG. IT WAS STATED THAT IF THE NURSE IS FAMILIAR WITH SETTING UP THE DEVICE AND KNOWS THAT IF SHE "PUSHED THE BUTTON THREE TIMES FO THE PROGRAM SHE WANTS AND ISN'T PAYING ATTENTION" THAT THE OPTION MENU HAS CHANGED, THERE IS POTENTIAL FOR MISPROGRAMMING THE DEVICE. THE RISK MANAGER REPORTS THAT THERE HAVE BEEN TWO UNDOCUMENTED INSTANCES WERE THE PCA PUMP "DEFAULTED TO 0.1MG/ML CONCENTRATION" AND "THE RN EITHER MIS-PROGRAMMED OR INCOMPLETELY PROGRAMMED" THE DEVICE. IN BOTH INSTANCES, THE ERROR WAS DISCOVERED WHEN PTS WERE TRANSFERRED TO OTHER UNITS (TRANSFERS UNRELATED TO THE PCA DELIVERY) AND UPON ASSESSMENT OF THE PTS, THEY WERE FOUND TO BE "LETHARGIC". THE PTS WERE PLACED ON OXYGEN AND MONITORED PROPHYLACTICALLY WITH PULSE OXIMETRY AND PCA WAS DISCONTINUED. NO OTHER INTERVENTIONS WERE REQUIRED. THE SETTINGS AND MEDICATION WERE UNKNOWN. THOUGH REQUESTED, THERE WAS NO FURTHER INFO AVAILABLE.