BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3479482 · Received November 20, 2013

    Report

    Report Number
    3004209178-2013-21151
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Report Date
    October 25, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A VOLUME DISCREPANCY WITH THE ACTUAL RESIDUAL VOLUME (ARV) LESS THAN THE EXPECTED RESIDUAL VOLUME (ERV). ON (B)(6) 2013 THE ARV WAS 1ML AND THE ERV WAS 4.1ML; ON (B)(6) 2013 THE ARV WAS 1ML AND THE ERV WAS 4.1ML; ON (B)(6) 2013 THE ARV WAS 1ML AND THE ERV WAS 7.9ML. THE HEALTHCARE PROVIDER (HCP) STATED THAT THERE WAS ALWAYS MORE THAN 20ML OF MEDICATION IN THE SYRINGE PRIOR TO REFILL AND THEY FILL THAT ENTIRE AMOUNT INTO THE PUMP BUT CAN ONLY PROGRAM 20ML. THE PATIENT DID NOT FEEL ANY SYMPTOMS CHANGE. THE PATIENT HAD A LITTLE INCREASED SORENESS. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL, CLONIDINE AND MARCAINE. IT WAS LATER REPORTED THAT ON (B)(6) 2013 THE ERV WAS 3.2ML AND THE ARV WAS 3.5ML, ON (B)(6) 2013 THE ERV WAS 1.5ML AND THE ARV WAS 3.0ML, ON (B)(6) 2013 THE ERV WAS 0ML AND THE ARV WAS 0ML, ON (B)(6) 2013 THE ERV WAS 1.9ML AND THE ARV WAS 2ML, ON (B)(6) 2013 THE ERV WAS 1.9ML AND THE ARV WAS 2ML, AND ON (B)(6) 2013 THE ERV WAS 0ML AND THE ARV WAS 0ML. PER THE HCP, THE ¿COCKTAIL¿ WAS PREPARED WITH 23ML AND THE PUMP WAS FILLED WITH AS MUCH OF THE 23ML AS POSSIBLE. THE NEXT REFILL WAS SCHEDULED FOR DECEMBER. IT WAS LATER REPORTED THAT THERE WERE NO SYMPTOMS. THE HCP WILL CONTINUE TO MONITOR VOLUMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604071 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Female