BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3162575 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10145
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD CHANGED THE CONCENTRATION OF DRUG BEING USED TO EXTEND THE PATIENT¿S REFILL INTERVAL. THE DRUG CONCENTRATION HAD INITIALLY BEEN AT 1000MCG/ML, BUT THE PUMP RATE HAD BEEN INCREASED TO 1300MCG/DAY DUE TO THE PATIENT¿S PAIN, WHICH RESULTED IN A REFILL INTERVAL OF 25 DAYS. ON THE DAY PRIOR TO REPORT, TO EXTEND THE INTERVAL, THE PHYSICIAN CHOSE TO REFILL THE PUMP WITH DRUG CONCENTRATED AT 2000MCG/ML. AT THAT TIME, THE PHYSICIAN FORGOT THAT HE HAD CHANGED THE CONCENTRATION AND DID NOT UPDATE ANY OF THE PUMP SETTINGS. AT THE TIME OF REPORT, ABOUT 22 HOURS HAD ELAPSED AND THE PHYSICIAN WAS ATTEMPTING TO REPROGRAM THE PUMP AND HAD STARTED A BRIDGE BOLUS ABOUT TEN MINUTES EARLIER. UPON REVIEW, IT WAS FOUND THAT THE BRIDGE BOLUS WASN¿T NECESSARY, BECAUSE ALL OF THE OLD DRUG WOULD HAVE ALREADY BEEN CLEARED FROM THE TUBING. IT WAS THEN THAT THE BRIDGE BOLUS WAS CANCELLED AND THE PUMP WAS UPDATED. IT WAS STATED THAT THE REFILL INTERVAL WAS STILL AT 27 DAYS WITH THE INCREASED DRUG CONCENTRATION. HOWEVER, IT WAS FOUND THAT THE PUMP RESERVOIR WAS ABLE TO HOLD 40ML AND THE PHYSICIAN HAD ONLY FILLED IT WITH 20ML OF DRUG. THE PHYSICIAN WAS UNSURE OF WHEN OR HOW HE HAD STARTED REFILLING ONLY 20ML OF DRUG, BUT HE FOUND THAT HE HAD STILL BEEN REFILLING WITH 40ML IN (B)(6) 2012. THE PHYSICIAN COULD NOT RECALL A TIME THAT THERE HAD BEEN A HUGE VOLUME DISCREPANCY AND SPECULATED THAT HE MIGHT HAVE BEEN SENT THE WRONG VOLUME OF SYRINGE BY THE PHARMACY ONCE. IT WAS STATED THAT, AT THE TIME OF REPORT, THE PATIENT WAS DOING FINE. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263322 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR