BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3021343 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04236
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROVIDER UNINTENTIONALLY FILLED THE PUMP WITH A 2000 MICROGRAM PER MILLILITER CONCENTRATION AND NO BRIDGE BOLUS WAS PROGRAMMED. THE PROGRAMMING WAS LEFT AT 500 MICROGRAMS PER MILLILITER. THE PREVIOUS CONCENTRATION WAS 500. THE PATIENT WAS RECEIVING THE CORRECT DOSE/CONCENTRATION. THE CALCULATIONS PERFORMED NOTED THE CONCENTRATION WOULD LIKELY NOT REACH THE PATIENT FOR APPROXIMATELY 16 HOURS. THE PATIENT WAS REPORTED AS "CLINICALLY FINE" AND ASYMPTOMATIC AND HAD LEFT THE CLINIC. THE PATIENT WAS BEING CONTACTED TO ADDRESS THE BRIDGE BOLUS PROGRAMMING. THIS DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122918 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1