Description of Event or Problem · 1
THE DEVICE WAS IMPLANTED IN 7/96 FOR INFUSION OF FUDR THROUGH THE HEPATIC ARTERY FOR TREATMENT OF CANCER. ON 8/30/96, THE FACILITY NURSE CONTACTED A MFR NURSE AND REPORTED THAT THREE WEEKS POST IMPLANT, THE DEVICE RAN DRY. THE DEVICE WAS THEN REFILLED, AFTER CHECKING NEEDLE PLACEMENT, AND THE SIDEPORT FLUSHED EASILY. ON 8/23/96, SEROUS FLUID WAS NOTED IN THE DEVICE POCKET. THE DEVICE WAS ACCESSED WITHOUT DIFFICULTY, FLOW RATE(FR)=4ML/DAY (PREDICTED FLOW RATE= 2.25ML/DAY). THE PT HAD A LOW GRADE FEVER AT THAT TIME. AT THE NEXT DEVICE REFILL ON 8/26/96, IT WAS NOTED THAT THE PT'S SKIN TONE WAS NORMAL AND THERE WAS MUCH SWELLING; HOWEVER, LESS THAN AT THE PREVIOUS REFILL ON 8/23/96. CLEAR SEROUS FLUID WAS ASPIRATED FROM THE DEVICE POCKET; HOWEVER, IT WAS NOT SENT FOR CULTURE. THE DEVICE WAS STILL FLOWING AT 4ML/DAY. ON 8/30/96, CLEAR SEROUS FLUID WAS ASPIRATED FROM THE DEVICE POCKET; HOWEVER, IT WAS NOT SENT FOR CULTURE. THE DEVICE WAS STILL FLOWING AT 4ML/DAY. ON 8/30/96, A LARGE AREA WAS NOTED EXTENDING TOWARD THE PT'S HIP WHICH WAS HARD IN AREAS AND HAD "A GREENISH BRUISING, LIKE AN OLD BRUISE". THERE HAD BEEN NO SKIN TEMPERATURE CHANGES AND NO NEW TRAUMA TO THE AREA. THE DEVICE FLOW RATE WAS NOW 3 ML/DAY. THE FACILITY NURSE STATED THAT THE PHYSICIAN WANTED TO BEGIN CHEMOTHERAPY ON TUESDAY, SEPT 3,96. THE MFR NURSE QUESTIONED IF THE DEVICE CATHETER HAD BEEN PUNCTURED WHEN THE DEVICE POCKET WAS ASPIRATED. SHE THEN STATED THAT IF THE AREA IS NOT IMPROVED BY 9/3/96, THEN IT WOULD BE NECESSARY TO PERFORM A DYE STUDY THROUGH THE DEVICE SIDEPORT. IF THE AREA IS NO WORSE AT THAT TIME, THEN THE PHYSICIAN COULD WAIT FOR THE 9/6/96 DEVICE REFILL TO MAKE A DECISION ABOUT THE SIDEPORT STUDY. THE MFR NURSE ALSO RECOMMENDED THAT ANY FURTHER ASPIRATE BE SENT FOR CULTURE.