Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING BLACKOUT/PASS OUT EPISODES, URINARY RETENTION, SWOLLEN AND DISCOLORED (PURPLE) FEET AND LOWER LEGS, NUMBNESS IN LEGS, "PINS AND NEEDLES' SENSATION IN LEGS, AND UNSPECIFIED BLOOD PRESSURE IRREGULARITIES SINCE BACLOFEN WAS ADDED TO THE PATIENT'S PUMP IN 2008. SYMPTOMS BEGAN FOLLOWING A REFILL SESSION. THE PATIENT WAS AT HOME AND REPORTED TO BE IN "FAIR" CONDITION, ALTHOUGH, THE PATIENT WAS EMOTIONALLY DISTRESSED (CRYING). IT WAS REPORTED THAT THE PATIENT LOST HER PUMP HEALTH CARE PROVIDER FEW DAYS LATER, AND HAD BEEN UNABLE TO LOCATE ANOTHER HCP TO TAKE HER CASE. THE PRIMARY CARE PHYSICIAN HAD BEEN HELPFUL BUT WAS NOT ABLE TO WORK WITH THE PUMP. AN ALARM WAS HEARD BUT NOT CONFIRMED BY TELEMETRY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL AND WAS IN THE HOSPITAL AND BEING DISCHARGED. THE PUMP HAD BEEN INTERROGATED AND IT WAS INDICATED THAT TWO ALARMS HAD OCCURRED AND THAT THERE WAS NO MEDICATION IN THE PATIENT'S RESERVOIR. AT ABOUT 4 MONTHS LATER, IT WAS REPORTED THAT THE PATIENT WAS "BLACKING OUT", HAD DECREASED POTASSIUM, AND URINE RETENTION. IT WAS FURTHER REPORTED BY AN EMERGENCY ROOM PHYSICIAN ABOUT ONE MONTH PRIOR, THAT THE PATIENT WAS EXPERIENCING WEAKNESS IN THE LEGS AND INCREASED PAIN OVER THE PAST FEW MONTHS BUT THAT THERE WERE NO NEW SYMPTOMS SINCE THE ALARM BEGAN TWO DAYS AGO. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING DELIVERED VIA THE PUMP WERE NOT REPORTED. THE PATIENT REPORTED "BLACKING OUT" AFTER BEING DISCHARGED FROM THE HOSPITAL TWICE THIS MORNING. LOW BLOOD PRESSURE WAS ALSO REPORTED (NO VALUES WERE PROVIDED). THE PATIENT WAS AT HOME AT THE TIME OF THE CALL. IT WAS INDICATED THAT THE PUMP WOULD BE REMOVED DUE TO MULTIPLE HEALTH ISSUES. IT WAS ALSO REPORTED THAT THE PUMP WAS INFECTED AND THAT NO OTHER PHYSICIAN WAS ABLE TO FOLLOW THE PATIENT'S BACLOFEN AND DILAUDID THERAPY. THE PUMP WAS LAST CHECKED WHEN BACLOFEN WAS ADDED, AND THE PATIENT WAS DUE FOR A REFILL IN ABOUT 5 MONTHS LATER. THE PUMP WAS REPORTEDLY AT LOW RESERVOIR. SOME FEW DAYS TO REFILL, IT WAS FURTHER REPORTED THAT THE PATENT HAD BEEN HOSPITALIZED FOR 2 DAYS (NOT CLEAR IF THIS WAS THE HOSPITALIZATION ABOUT 8 DAYS PRIOR, OR A NEW ADMISSION) AND NOW HAD AN INFECTION AT THE PUMP POCKET SITE FOR 2 DAYS. THE PUMP HAD BEGUN TO ALARM APPROXIMATELY ABOUT 40 DAYS PRIOR, AND A CRITICAL ALARM WAS NOTED AT THE TIME OF THE REPORT. THE PATIENT STILL DID NOT HAVE A PHYSICIAN TO MONITOR HER PUMP BUT SHE WAS SEEKING MEDICAL ATTENTION WHEN NEEDED. AS OF THIS DATE IT WAS INDICATED THAT THE PHYSICIANS WERE TRYING TO DECREASE THE MEDICATION THAT WAS LEFT IN THE PUMP AND THEN PLANNED TO EXPLANT. THE PATIENT INDICATED THAT THE TITRATION MADE HER VERY ILL. A FEW DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL (DATE OF HOSPITALIZATION WAS NOT PROVIDED AND MAY OR MAY NOT HAVE BEEN REPORTED IN THE PREVIOUS CALL). THE CALLER REPORTED THAT THE PATIENT HAD "PASSED OUT AND HAD POTASSIUM LEVEL OF 2". IT WAS THOUGHT THAT THE PATIENT MAY BE RELEASED ON THIS DATE. IT WAS INDICATED THAT THE PATIENT NEEDED TO FIND A PRIMARY CARE PHYSICIAN TO MANAGE HER CARE AND MAKE A CLINICAL DECISION ON HER CARE. THE PATIENT HAD RECENTLY SWITCHED INSURANCES AND WAS IN THE PROCESS OF FINDING A PCP. IT WAS ALSO INDICATED THAT OTHER PHYSICIANS WOULD EXPLANT THE DEVICE BUT THE PATIENT NEEDED TO HAVE A PHYSICIAN MANAGING HER CARE TO ENSURE THE PUMP WAS TITRATED DOWN AND COULD BE SAFELY EXPLANTED WITHOUT AN ADVERSE EVENT. THE CONCENTRATION ADN DOSE INFORMATION WAS NOT PROVIDED.