Description of Event or Problem · 1
LITERATURE: PERRUCHOUD C., BOVY M., DURRER A., ROSATO M., RUTSCHMANN B., MUSTAKI J.-P., BUCHSER E. 2011. SEVERE HYPERTENSION FOLLOWING ACCIDENTAL CLONIDINE OVERDOSE DURING THE REFILLING OF AN IMPLANTED INTRATHECAL DRUG DELIVERY SYSTEM. NEUROMODULATION 2011; E-PUB AHEAD OF PRINT. DOI: 10.1111/J.1525-1403.2011.00392. SUMMARY: THE AUTHORS REPORT ON COMPLICATIONS ASSOCIATED WITH INTRATHECAL PUMPS THAT MAY BE LINKED TO THE SURGICAL PROCEDURE, THE IM PLANTED DEVICE, OR THE MEDICATION ITSELF. REPORTABLE EVENT: THE AUTHORS REPORTED THAT AFTER 14 MONTHS, A (B)(6) MALE EXPERIENCED A REFILL ISSUE. ON THE DAY OF THE INCIDENT, THE PUMP WAS REFILLED WITHOUT PROBLEM WITH 40 ML OF CLONIDINE 900 MG/ML. THE DEVICE WAS PROGRAMMED AT A RATE OF 43 MG/DAY (DAILY FLOW RATE OF 0.05 ML) AND THE PATIENT-CONTROLLED CAPABILITY WAS ENABLED, ALLOWING THE PATIENT TO SELF-ADMINISTER UP TO 13 BOLUSES OF 40 MG (44 ML) WITH A 90-MIN LOCKOUT INTERVAL. WITHIN 30 MIN AFTER AN APPARENTLY UNEVENTFUL REFILL PROCEDURE, THE PATIENT WAS ADMITTED BECAUSE OF IMPAIRED CONSCIOUSNESS AND SEVERE ARTERIAL HYPERTENSION (192/143 MMHG). THE PUMP WAS CHECKED SHOWING THE INTENDED PROGRAMMING WAS CORRECT, AND THE RESIDUAL VOLUME OF THE RESERVOIR WAS CONSISTENT WITH THE TIME ELAPSED SINCE REFILL. NO SELF-ADMINISTERED BOLUS WAS USED SINCE THE REFILL. THE PUMP WAS EMPTIED AND ONLY 36.7 ML (OUT OF THE 40 ML THAT HAD BEEN REFILLED ONE HOUR AGO) COULD BE RETRIEVED. THE DOSE THAT LEAKED IN THE SURROUNDING TISSUE DURING REFILL WAS ESTIMATED AT 3.3 ML, WHICH AMOUNTS TO APPROXIMATELY 3MG OF CLONIDINE. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR MONITORING AND TREATMENT OF THE SEVERE HYPERTENSION WITH INTRAVENOUS PHENTOLAMINE AND NITRATES. THE PATIENT REGAINED CONSCIOUSNESS WITHIN AN HOUR AND THE HYPERTENSION WAS CONTROLLED AND STABLE WITHIN THE NEXT 12 HOURS. HE WAS DISCHARGED ON THE NEXT DAY WITHOUT SEQUEL. THE IT DRUG DOSE AND FLOW RATE REMAINED UNCHANGED AND THE PATIENT'S PAIN REMAINED WELL CONTROLLED. THE AUTHORS INDICATED THAT THE "SHORTER DISTANCE, NEARLY 6 MM, BETWEEN THE OUTER BORDER OF THE SILICONE SEPTUM AND THE FLOOR IN THE RESERVOIR MAKES THE PUNCTURE MORE DIFFICULT". THE AUTHOR ALSO INDICATES THAT "ALTHOUGH THE MANUFACTURER PROVIDES DEDICATED REFILL KITS, OUR STANDARD REFILL PROCEDURE WAS TO USE A 24-GAUGE NEEDLE ON A THREE-WAY CONNECTOR DIRECTLY ON THE SYRINGE, A SYRINGE CHANGE IS REQUIRED IF 20 ML SYRINGES ARE USED AS IT IS IN OUR CASE". THE AUTHORS INDICATED THAT THEY BELIEVE NEEDLE DISLOCATION OCCURRED DURING THE REFILL PROCEDURE WITH ENSUING SPILLING OF VARIOUS DRUG DOSES IN THE PUMP POCKET.