BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201258 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11174
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: 8591-38, LOT# D17878, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP CRITICAL ALARM WAS SOUNDING. THE PUMP WAS SUPPOSED TO HAVE BEEN FILLED ON (B)(6) 2013; THE LOW RESERVOIR ALARM WAS SET TO 1 OR 2 CC. THE PATIENT WAS GETTING 1000 MCG/DAY OF 2000 MCG/ML LIORESAL, SO IT WAS FELT THAT THE PUMP WAS PROBABLY EMPTY WITH THE FLOW RATE OF 0.5 ML/DAY. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR LATER IN THE DAY ON (B)(6) 2013, BUT THE PATIENT CAME IN EARLY. THE PHYSICIAN THOUGHT HE WAS NERVOUS. THE PATIENT WAS ASYMPTOMATIC. THE PHYSICIAN PLANNED TO REFILL THE PUMP. THE PHYSICIAN WAS CONSIDERING RESETTING THE LOW RESERVOIR ALARM TO 3 CC, SO THERE WOULD THEN BE 6 DAYS BETWEEN THE LOW RESERVOIR ALARM AND AN EMPTY RESERVOIR. IT WAS LATER REPORTED THAT THERE WAS CONFUSION REGARDING THE PUMP REFILL DATE. THE PUMP RAN OUT OF LIORESAL; THE PATIENT HAD NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303155 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR