BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201707 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00435
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    February 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THAT THIS EVENT WAS REPORTABLE. IT WAS REPORTED THAT THE PHYSICIAN HAD REFILLED THE PATIENT¿S PUMP WITH NEW DRUG. THE PHYSICIAN ASPIRATED THE CATHETER AFTER REFILLING THE PUMP WITH THE NEW DRUG BUT DID NOT CLEAR THE DRUG FROM THE PUMP TUBING. NEITHER PRIMING BOLUS NOR BRIDGE BOLUS WAS PERFORMED AFTER DRUG CHANGED. THE PUMP WAS INFUSING AT 5MG/ML CONCENTRATION AND 1 MG/DAY DOSE OR .2 ML/DAY FLOW RATE. TCV .23 ML. THE PATIENT WAS ¿FINE AND GOT A PATCH AND ALL KIND OF STUFF. JUST WASN¿T EFFECTIVE FOR HIM.¿ THE PATIENT WAS COMING BACK TO THE CLINIC TO CORRECT ISSUE WITH BRIDGE BOLUS PERFORMED. THE PATIENT WAS DOING WELL AND RECEIVING THERAPY. THE OLD DRUG WAS FENTANYL, AND THE CURRENT DRUG WAS MORPHINE DELIVERED IN THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302399 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR