Description of Event or Problem · 0
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) AND CONSUMER VIA A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL COMPOUNDED BACLOFEN 4,000 MCG/ML AT 1,100 MCG/DAY AND FENTANYL 75 MCG/ML AT 28 MCG/DAY VIA AN IMPLANTED PUMP FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA, VOMITING AND DIARRHEA 7 DAYS POST OPERATIVE. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS DIAGNOSED WITH AN ELEVATED WHITE BLOOD CELL COUNT (WBC) AND WAS DISCHARGED. THE PATIENT FELT IT WAS RELATED TO THE PUMP REPLACEMENT AND CONCERNED THAT IT WAS EITHER AN OVERDOSE OR UNDERDOSE BASED ON SPASTICITY CHANGE WITHIN THE WEEK. THE PATIENT THOUGHT IT WAS THE CATHETER, BUT THE MANAGING PHYSICIAN ASSISTANT MADE A CORRECTION WITH MEDICATION CONCENTRATION AND DECREASED THE INFUSION RATE. DIAGNOSTICS/TROUBLESHOOTING PERFORMED INCLUDED THE PATIENT WENT TO THE MANAGING PHYSICIAN OFFICE TO HAVE THE PUMP INTERROGATED AND CHANGES WERE UPDATED TO REFLECT CORRECT DRUG CONCENTRATION AND DECREASED INFUSION RATE. THE PUMP INFUSION RATE DECREASED, AND THE DRUG CONCENTRATION WAS CHANGED. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PATIENT WAS STABLE AND FOLLOWING UP WITH THE MANAGING PHYSICIANS. IT WAS FURTHER REPORTED THAT THE PUMP WAS REPLACED IN 2019 WITH A FLOWONIX. THE FLOWONIX PUMP WAS REPLACED WITH MEDTRONIC 20 ML ON (B)(6) 2025. THE PATIENT NOTED THE ORIGINAL CATHETER SINCE 2002, BUT THE PUMP CONNECTOR WAS REPLACED FROM THE FLOWONIX CONNECTOR TO THE 8596SC ON (B)(6) 2025. THE DRUG WAS TRANSFERRED, AND THE CATHETER WAS ASPIRATED, ALTHOUGH THE ORIGINAL LENGTH WAS UNKNOWN. THE PUMP WAS PROGRAMMED AND THE DRUG CONCENTRATION FOR SECONDARY DRUG WAS ¿MIS CATALOGUED¿. THE IMPLANTING PHYSICIAN REVIEWED AND UPDATED THE PUMP. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).