BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3120924 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07945
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) ATTEMPTED TO ASPIRATE THE CATHETER INTRAOPERATIVELY AND WAS ONLY ABLE TO PULL BACK APPROXIMATELY 0.1 MILLILITERS TOTAL. THE HCP REPORTEDLY TRIED TO ¿ASPIRATE AT THE END OF THE SUTURELESS CONNECTOR, HOOKED UP TO THE PUMP AND USED CATHETER ACCESS PORT NEEDLE.¿ IT WAS REPORTED A BACK TABLE PUMP PRIME WAS PERFORMED AND THAT THE HCP PLANNED TO LOOK INTO A DYE STUDY AT A LATER DATE. IT WAS NOTED THE PATIENT STATUS AT THE TIME OF THE REPORTER WAS ¿ALIVE ¿ NO INJURY/NO ADVERSE EVENT¿ AND NO PATIENT SYMPTOMS OR INJURIES WERE REPORTED RELATED TO THE EVENT. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE REPLACEMENT OF A PUMP FOR END OF LIFE AND A REVISION TO A SUTURELESS CATHETER, LIMITED ABILITY TO ASPIRATE WAS NOTED. IT WAS SUSPECTED THAT IT WAS POSSIBLY RELATED TO HIGH CONCENTRATIONS OF INTRATHECAL MEDICATIONS. A CATHETER DYE STUDY WAS PENDING AND WAS DISCUSSED. THERE WAS NO INJURY OR HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222493 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR