Description of Event or Problem · 1
IN 2009, THE BAXTER TECHNICAL SERVICES ASSOCIATE (TSA) CALLED CORPORATE PRODUCT SURVEILLANCE TO RELAY THAT A REPORT WAS RECEIVED FROM THE FACILITY BIOMEDICAL TECHNICIAN (BT) ON THAT DAY, FOR ONE UNKNOWN FLOGARD 6301 PUMP IN WHICH A 10-FOLD-OVER INFUSION OF UNSPECIFIED INSULIN WAS DETECTED AFTER PATIENT INFUSION WAS PERFORMED AT ABOUT 4 DAYS PRIOR. THE BT SAID THAT HE DOES NOT KNOW WHICH CHANNEL THE OVER INFUSION OCCURRED ON, OR IF THE ERROR WAS A USE/USER ERROR OR A PROBLEM WITH THE PUMP. THE BT WAS ASKED TO CHECK THE PUMP FUNCTION AFTER THE INCIDENT OCCURRED. THE PUMP WAS RECEIVED WITHOUT THE TUBING OR MEDICATION INTACT AND THE BT COULD NOT IDENTIFY ANY PROBLEMS WITH THE PUMP. THE BT SAID THAT HE TESTED THE PUMP AND COULD NOT CONFIRM THE MALFUNCTION. IN THE DAY OF REPORT, DURING A FOLLOW UP CALL TO THE BT, PRODUCT SURVEILLANCE LEARNED THAT THE NURSE SET THE PUMP AT A RATE OF 8ML PER HOUR. FORTY MINUTES FOLLOWING THE START OF INFUSION, THE PUMP ALARMED AND THE BAG WAS EMPTY. THE NURSE RETURNED TO CHECK ON THE PATIENT AND SAW THAT THE PUMP HAD INFUSED 80ML PER HOUR AND THE PUMP WAS SET AT THIS RATE. THE NURSE THOUGHT THERE MAY BE A PROBLEM WITH PUMP KEYPAD. THE BT COULD NOT CONFIRM A PROBLEM WITH PUMP KEYPAD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE PUMP WAS LAST SERVICED IN JANUARY OF 2009. THE BT INDICATED THAT A SECOND PUMP (RENTAL) MAY HAVE BEEN THE ACTUAL PUMP INVOLVED IN THIS INCIDENT. THAT PUMP IS OWNED BY UHS AND WAS RETURNED TO UHS FOR EVALUATION. AT APPROX ONE WEEK LATER, THE FOLLOWING INFORMATION WAS OBTAINED FROM THE ASSISTANT NURSE TO THE RISK MANAGER AT THE FACILITY, CLARIFYING THE EVENT THAT OCCURRED. THE PATIENT WAS ADMITTED TO THE FACILITY EMERGENCY ROOM WITH COMPLAINTS OF VOMITING AND ABDOMINAL PAIN AT 12:53 PM ON THE DAY OF THE EVENT. THE PATIENT STATED HIS BLOOD SUGAR WAS 584 THAT MORNING. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 808 WHEN TESTED AT THE HOSPITAL AT 1:00 PM. THE PATIENT WAS GIVEN DONNATAL ELIXIR, BENADRYL AND NORMAL SALINE FOR TREATMENT OF STOMACH UPSET AND PAIN. THE PATIENT'S BLOOD SUGAR WAS 627 AT 3:25 PM. FOR TREATMENT OF HIGH BLOOD SUGAR, THE PATIENT WAS PRESCRIBED INSULIN (NOVALIN R MANUFACTURED BY NOVONORDISK), 8 MILLILITERS (ML)/HOUR. THE BAG CONTAINED 100 UNITS OF INSULIN MIXED WITH 100 CUBIC CENTIMETERS (CC) OF NORMAL SALINE. THE PUMP WAS REPORTED TO HAVE BEEN SET AT A RATE OF 8ML/HOUR. INFUSION WAS STARTED WITHOUT INCIDENT AND THE NURSE LEFT THE ROOM. THE BAG WAS HUNG AT 4:21 PM AND THE "END OF BAG" ALARM WAS DISCOVERED AT 5:22 PM. IT IS BELIEVED THAT THE PATIENT RECEIVED MOST OF THE BAG OR UP TO 100 UNITS OF INSULIN. THE PATIENT'S BLOOD SUGAR WAS 164 AT END OF INFUSION. THE PATIENT WAS ADMINISTERED 1 AMPOULE OF D50, 100CC OF D5W AND 500CC OF D10 TO TREAT INSULIN OVERDOSE. AT 5:53 PM, PATIENT'S BLOOD SUGAR WAS 194. THE PATIENT'S BLOOD SUGAR WAS 182 AT 6:24 PM. THE FACILITY IS NOT SURE IF THE PUMP INVOLVED WAS A FACILITY OWNED PUMP OR A RENTAL PUMP FROM UNIVERSAL HOSPITAL SERVICES (UHS). THE SUSPECTED PUMPS WERE TAKEN OUT OF SERVICE. THE RENTAL PUMP WAS RETURNED TO UHS A DAY PRIOR TO REPORT, AND THE FACILITY OWNED PUMP WAS TESTED BY THE FACILITY BIOMED AND THEN RETURNED TO BAXTER FOR EVALUATION. THE PATIENT WAS RELEASED FROM THE HOSPITAL ABOUT 2 DAYS PRIOR TO REPORT. PATIENT IS RECEIVING 70-30 INSULIN AND HIS HEMOGLOBIN AIC TEST WAS 10.8 UPON RELEASE.