Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS AN INCIDENT WHERE THE ALARIS DEVICE WAS PROGRAMMED TO RUN OVER 24 HOURS AND WAS COMPLETE WITHIN 4 HOURS. THE CUSTOMER LATER PROVIDED THE FOLLOWING INFORMATION: THE EVENT OCCURRED ON (B)(6) 2025 AT 2:30AM. THE INFUSION WAS METHOTREXATE WITH AN INTENDED INFUSION RATE OF 20ML/HR AND A VOLUME TO BE INFUSED OF 470ML (OVER 23.5 HOURS AT 20ML/HR). THE INFUSION CONCENTRATION WAS METHOTREXATE 5, 445MG IN 470ML OF DEXTROSE 5%. IT WAS ALSO NOTED THAT THERE WAS A VINCRISTINE 2MG IN 25ML (BOLUS INFUSION) AND D5W 1/2NS WITH SODIUM BICARBONATE 40MEQ/L 1,000ML INFUSION RUNNING AT 151 ML/HR INFUSIONS RUNNING AT THE TIME OF EVENT. IT WAS REPORTED THAT 400ML HAD INFUSED IN ABOUT 4 HOURS. THE CUSTOMER ALSO LATER CLARIFIED THAT THE ERROR WAS DISCOVERED WHEN THE NURSE NOTICED THE PUMP ALARMING FOR AIR-IN-LINE, AND SUBSEQUENTLY THAT THE BAG WAS EMPTY AFTER ONLY SEVERAL HOURS, INSTEAD OF THE EXPECTED 24 HOURS. THE PATIENT REQUIRED A REPEAT PROCEDURE WHICH INCLUDED A REPEAT LUMBAR PUNCTURE AND REPEAT INFUSION. RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA WHICH STATES, "INFUSION PUMP WAS PROGRAMMED TO RUN 20 ML/HR FOR 23.5 HOUR METHOTREXATE INFUSION. INFUSION ALARMED EMPTY AFTER 4 HOURS. PUMP RAN WRONG RATE AND/OR RAN AT GRAVITY, DESPITE THE TUBING BEING INSERTED CORRECTLY AND THE PUMP BEING PROGRAMMED CORRECTLY." THE ROOT CAUSE OF THE OVER INFUSION OF METHOTREXATE WAS NOT IDENTIFIED DURING THE INVESTIGATION. HOWEVER, THE USE OF THIRD-PARTY PARTS MAY HAVE BEEN A CONTRIBUTING FACTOR.