BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2180994 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05703
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A REFILL THAT WAS DONE ON (B)(6) 2011, THE CONCENTRATION OF LIORESAL WAS CHANGED FROM 500 MCG/ML TO 2000 MCG/ML. A BRIDGE BOLUS WAS NOT PERFORMED AND THE PUMP WAS NOT UPDATED/PROGRAMMED TO REFLECT THE DRUG CONCENTRATION CHANGE; AN OVERDOSE OCCURRED. THE PT WAS HOSPITALIZED. IT WAS CONFIRMED THROUGH CALCULATIONS THAT THE 500 MCG/ML DRUG CONCENTRATION WOULD HAVE BEEN CLEARED FROM THE SYSTEM IN APPROX 28 HRS, WITH THE PUMP LEFT PROGRAMMED TO 500 MCG/ML. IT WAS FURTHER NOTED THAT ONCE THE 500 MCG/ML DRUG CONCENTRATION WOULD HAVE CLEARED THE SYSTEM, THE PT WOULD HAVE BEEN RECEIVING A DOSE OF 640 MCG/DAY VS THE 160.23 MCG/DAY PROGRAMMED IN THE PUMP. THE PUMP WAS PROGRAMMED TO A SIMPLE CONTINUOUS MINIMUM RATE ON (B)(6) 2011, DUE TO OVERDOSE SYMPTOMS. ON (B)(6) 2010, IT WAS CONFIRMED VIA TELEMETRY THAT THE PUMP WAS STILL IN SIMPLE CONTINUOUS MODE. ADDITIONAL INFO WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| O PROGRAMMER: MODEL 8840, LOT# UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N167637031| EXPLANTED: