BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3072723 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06738
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PATIENT WAS REFILLED ON (B)(6) 2013. THEY WERE SUPPOSED TO HAVE BETWEEN FIVE AND SIX MILLILITERS, BUT THEY PULLED OUT ABOUT 0.2 ML. IT WAS UNKNOWN IF THERE WAS A HISTORY OF VOLUME DISCREPANCIES. IT WAS NOT KNOWN IF THE PATIENT WAS ACCESSING THEIR OWN PUMP, IF A PARTIAL POCKET FILL HAD OCCURRED, OR IF THE PUMP HAD OVERINFUSED. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN. IT WAS LATER REPORTED THAT "THEY WERE NOT IN THE PORT." THE PATIENT WAS PUT UNDER FLUOROSCOPY, AND THEIR HEALTHCARE PROVIDER WAS ABLE TO PULL "EXACTLY THE CORRECT AMOUNT OUT OF THE PUMP." THE PATIENT'S PUMP WAS REFILLED. THERE WERE NO OTHER ISSUES TO REPORT AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175308 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other