Description of Event or Problem · 1
THREE COLLEAGUE INFUSION PUMPS AND BAXTER CLEARLINK SYSTEM (BURETROL ADD-ON SET CONNECTED TO THE CONTINUE FLO SOLUTION SET) WERE BEING USED ON AN INTENSIVE CARE UNIT PT. THE PT EXPIRED. THE SAME IV SET UP, BURETROL ADD ON SET CONNECTED TO CONTINUE FLO SOLUTION SET WAS USED ON EACH COLLEAGUE INFUSION PUMP. THE PT WAS ADMITTED TO THE INTENSIVE CARE UNIT ON AND WAS PLACED ON THE PUMPS AND IV SETS THE SAME DAY. THE PT HAD A DOUBLE LUMEN UMBILICAL ARTERIAL CATHETER (UAC) AND A SINGLE LUMEN UMBILICAL VENOUS CATHETER (UVC). ONE TPN BAG WAS BEING INFUSED VIA TWO DIFFERENT COLLEAGUEPUMPS: THE FIRST PUMP WAS REPORTED TO BE INFUSING AT A RATE OF 0.51ML/HR AND THE SECOND PUMP WAS REPORTED TO BE INFUSING AT A RATE OF 2ML/HR. A THIRD PUMP WAS INFUSING 100ML BAG OF HEPARIN, CONCENTRATION OF 50 UNITS IN 0.45 NORMAL SALINE, AT THE REPORTED RATE OF 1.1ML/HR. A PRESSURE PROBE AND TRANSDUCER WITH A STOPCOCK, AND ADDITIONAL STOPCOCK WITH A 1ML SYRINGE, WERE ATTACHED TO THE TUBING ON THIS PUMP. THE PUMPS WERE REPORTED TO BE PROGRAMMED IN "ML/HR" MODE. THE IV TUBING WAS CONNECTED TO THE PT VIA SEPARATE LUMENS; HOWEVER, INFORMATION WAS NOT AVAILABLE FROM THE FACILITY REGARDING WHICH TUBING WAS CONNECTED TO THE UMBILICAL ARTERIAL CATHETER AND WHICH TO THE UMBILICAL VENOUS CATHETER. INFORMATION WAS NOT AVAILABLE FROM THE FACILITY REGARDING WHETHER OR NOT THERE WERE ANY EXTENSION SETS OR INJECTION SITES USED AS A CONNECTION BETWEEN IV TUBING AND THE PT'S CATHETER. REPORTEDLY, BETWEEN APPROXIMATELY 1820-1838 THE IV TUBING WAS CHANGED ON "3 LINES" AND "SHORTLY AFTER, THE PT'S CONDITION DETERIORATED", WHICH PROGRESSED TO CARDIOPULMONARY ARREST. THE PT COULD NOT BE RESUSCITATED AND EXPIRED THE SAME DAY AT 1945. THE FACILITY'S RISK MANAGER REPORTED THE PT DIED DUE TO AN AIR EMBOLISM. AN X-RAY WAS PERFORMED AND REVEALED AN AIR-EMBOLISM. THE REPRESENTATIVE OF THE FACILITY'S LEGAL DEPARTMENT BELIEVED THE X-RAY WAS PERFORMED DURING RESUSCITATION, WHEN THE PT WAS INTUBATED. ACCORDING TO THE RISK MANAGER, THE SOURCE OF AIR EMBOLISM WAS NOT DETERMINED AND IT WAS UNKNOWN HOW THE PT DEVELOPED THE CONDITION (AIR EMBOLISM). AN AUTOPSY WAS PERFORMED AND CONFIRMED AIR-EMBOLISM. THE DEATH CERTIFICATE OR AUTOPSY REPORT HAS BEEN REQUESTED BY BAXTER FROM THE FACILITY, HOWEVER THEY WERE NOT MADE AVAILABLE TO BAXTER. ACCORDING TO THE REPRESENTATIVE OF THE FACILITY'S LEGAL DEPARTMENT, THE HOSPITAL WAS STILL AWAITING THE AUTOPSY REPORT FORM THE MEDICAL EXAMINERS OFFICE. DESPITE BAXTER'S EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTING FACILITY, DETAILS WERE NOT AVAILABLE REGARDING WHETHER OR NOT THE BAGS AND THE IV SETS WERE CHANGED AT THE SAME TIME, ANY OTHER PARTS OF THE INFUSION SET UP (SUCH AS EXTENSIONS SETS IF ANY) CHANGED AT THE TIME THE IV TUBING WAS CHANGED, SIZE AND LOCATION OF EMBOLISM, AND AUTOPSY REPORT. THIS EVENT WAS ALSO SUBMITTED VIA 30 DAY MEDWATCH #6000001-2005-00880, #6000001-2005-00881, AND #6000001-2005-00882, #6000001-2005-01121, #6000001-2005-01124, #6000001-2005-01125, #6000001-2005-01126, AND #6000001-2005-01128.