BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3242582 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12151
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOWING A CATHETER DYE STUDY, A REPRESENTATIVE REPORTED THAT THEY CHANGED THE CATHETER VOLUME AND WENT TO UPDATE THE PUMP WITH THE BOLUS TO PRIME THE CATHETER. HALFWAY THROUGH THE TELEMETRY IN PROGRESS, A PUMP MEMORY ERROR OCCURRED. THE 8840 INDICATED A ¿PUMP MEMORY ERROR, TELEMETRY CANCELLED.¿ THIS WAS NOTED TO HAVE OCCURRED THREE TIMES. THE LOGS INDICATED THE PUMP WAS STOPPED. THE PATIENT¿S SIMPLE CONTINUOUS RATE WAS RE-PROGRAMMED AND THE PUMP WAS UPDATED OUT OF STOPPED PUMP MODE. A PRIMING BOLUS WAS PLANNED USING A VOLUME OF 0.196 ML. THE REPRESENTATIVE ALSO NOTED THAT ERI OCCURRED, AND IT HAD SCHEDULED TO REPLACE THE PUMP BY (B)(6) 2013. THE MEDICATIONS USED WITHIN THE SYSTEM WERE DILAUDID, CLONIDINE, BACLOFEN, AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342209 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR