ASCENDA

Additional Manufacturer Narrative

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8637-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: PUMP. (B)(4).

Description of Event or Problem

INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING FENTANYL (600UG/ML AT 100UG/DAY), CLONIDINE (CONCENTRATION/DOSE UNKNOWN), AND BUPIVACAINE (CONCENTRATION/DOSE UNKNOWN) VIA AN IMPLANTED PUMP. INDICATION FOR USE WAS NOTED AS NON-MALIGNANT PAIN AND RADICULOPATHY. IT WAS REPORTED THAT THE PATIENT HAD INFECTION SYMPTOMS AND "MENINGEAL SIGNS"/PRESENTING MENINGITIS. THE PATIENT FIRST PRESENTED REPORTING "DISORIENTATION." THE INFECTION WAS CONFIRMED. THE EVENT OCCURRED ON (B)(6) 2015. THE HEALTHCARE PROVIDER (HCP) WITHDREW FLUID FROM THE SIDEPORT ON (B)(6) 2015 AND PULLED OUT A PINK, MILKY FLUID." THEY DID LABS ON (B)(6) 2015 AND THE RESULTS WERE "ELEVATED RED BLOOD CELLS, GLUCOSE WAS LOW AND GRAM STAIN WAS NEGATIVE." AS OF (B)(6) 2015, TREATMENT WAS ON-GOING. ON (B)(6) 2015, A CATHETER ACCESS PORT (CAP) PROCEDURE WAS PERFORMED. THE CATHETER WAS ASPIRATED SUCCESSFULLY. THE HCP PROGRAMMED A SINGLE BOLUS OF 24 UG (.04ML) HOWEVER THAT WAS NOT ENOUGH. THE CATHETER VOLUME WAS .247ML. THE REMAINING VOLUME TO BE PRIMED WOULD BE 124UG, IF 30 MINUTES HAD PASSED SINCE PROGRAMMING, THE HCP MAY ADJUST TO 122UG INSTEAD (SINGLE BOLUS). THE PHYSICIAN QUESTIONED IF THE PUMP AND MEDICATIONS WOULD EVER CAUSE A CHEMICAL MENINGITIS.