BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3903931 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12309
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICIAN PUT A HIGHER CONCENTRATION OF BACLOFEN THAN INTENDED INTO THE PATIENT¿S PUMP. THE CLINICIAN WANTED THE PATIENT TO GET A DOSE OF ¿~100MCG/DAY OF BACLOFEN¿ BUT CALCULATED THAT THE PATIENT WOULD RECEIVE ¿~886MCG/DAY¿ AFTER THE BRIDGE WAS COMPLETE. IT WAS REPORTED THAT THE CLINICIAN DECIDED TO CHANGE OUT THE CONCENTRATION, SO SHE WILL BRING THE PATIENT BACK PRIOR TO THE BRIDGE COMPLETING AND WOULD DO A ¿REMOVING SYSTEM CONTENTS PROCEDURE¿ TO REMOVE THE OLD DRUG FROM THE PUMP TUBING, CATHETER AND RESERVOIR SO THAT THE PATIENT NEVER RECEIVES THE HIGHER BACLOFEN DOSE. THE PUMP SYSTEM WAS DELIVERING BACLOFEN AND DILAUDID. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURE REPRESENTATIVE MET WITH THE PATIENT AND PHYSICIAN. THE PATIENT¿S PUMP WAS ¿WASHED OUT¿ WITH PRESERVATIVE FREE (PF) NORMAL SALINE, FILLED WITH NEW DRUG, THREE BOLUSES WERE PERFORMED TO CLEAR THE ROTOR AFTER ASPIRATIONS AND LASTLY A PRIMING BOLUS WAS PERFORMED. IT WAS REPORTED THAT TO THE MANUFACTURE REPRESENTATIVE¿S KNOWLEDGE THE PATIENT WAS ¿DOING WELL AS SHE WAS THAT DAY.¿ THE PHYSICIAN WAS TRYING TO MIX DRUGS, DEPENDED ON A PHARMACY WITH LITTLE KNOWLEDGE, THE CONCENTRATION WAS WAY TOO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379819 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR