Description of Event or Problem · 1
ON 2/13/2009 BAXTER REVIEWED THE MAUDE DATABASE AND FOUND THE FOLLOWING REPORT DATED 7/30/2008, INVOLVING A COLLEAGUE GUARDIAN IV PUMP, PRODUCT CODE AND SERIAL NUMBER UNK, WHICH WAS INVOLVED IN A PT DEATH. THE ACTUAL DATE OF THE EVENT AND THE FACILITY ARE UNK. ACCORDING TO THE REPORT, THE "SMART" PUMP WAS INFUSING DOPAMINE, VASOPRESSIN AND NORMAL SALINE AT A TO KEEP OPEN RATE. OTHER PT CARE INCLUDED X-RAY IN PROCESS. SHORTLY AFTER THE X-RAY, THE SYSTOLIC BLOOD PRESSURE (SBP) DECREASED TO 60'S. ON ENTRY TO ROOM THE PUMP WAS NOTED TO BE "OFF." THE SMART PUMP WAS TURNED ON, INFUSIONS WERE RESUMED AT INCREASED DOSES, FLUID VOLUME RESUSCITATION, DECREASED LEVEL OF CONSCIOUSNESS (LOC) LED TO PT INTUBATION TO PROTECT AIRWAY. TEST OF SEVERAL INFUSION PUMPS FOUND THAT THE PUMP WILL "SHUT OFF" WITH SINGLE PUSH OF LIGHT/MODERATE TOUCH OF ON/OFF BUTTON. NO WARNINGS OR PROMPTS NOTED. PT OUTCOME POOR WITH CONTINUED DETERIORATION EVENING IN 2008. FAMILY DECISION TO STOP DRIPS MADE BY PHYSICIAN AND FAMILY AT 0117 IN THE NEXT DAY WITH PT DEMISE. ADDITIONAL INFO WAS RECEIVED FROM THE FDA WHO PROVIDED A COPY OF THE REPORT WHICH PROVIDED THE EVENT DATE AS 2008. THE SERIAL NUMBER REMAINS UNK AS WELL AS STATUS OF THE DEVICE. ON 2/19/2009, THE FACILITY'S RISK MGR PROVIDED THE FOLLOWING INFO: THE PT WAS STATUS POST LEFT THORACOTOMY WITH WEDGE RESECTION TWO DAYS PRIOR TO EVENT DATE. THE MALE PT HAD LUNG CANCER AND HAD SIGNIFICANT MEDICAL CONDITIONS WHICH CONTRIBUTED TO HIS DEMISE. ON THE EVENT DAY, THE PT WAS TAKEN FOR AN X-RAY. WHEN THE NURSE WENT BACK INTO THE ROOM, THE PUMP WAS FOUND TO BE TURNED OFF. IT APPARENTLY WAS BUMPED, AND THE PUMP WAS TURNED OFF. THE FACILITY BELIEVES IT TO BE A "KEYSTROKE ISSUE." THE PUMP SERIAL NUMBER IS UNK AND THE PUMP WAS NOT SEQUESTERED NOR AVAILABLE FOR EVAL. THE FACILITY PROVIDED EDUCATION TO THE STAFF THAT WHEN A PT INCIDENT OCCURS, THE PUMP MUST BE SEQUESTERED FOR EVALUATION.