BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3578959 · Received January 16, 2014

    Report

    Report Number
    3004209178-2014-00754
    Event Type
    Injury
    Date Received
    January 16, 2014
    Date of Event
    December 26, 2013
    Report Date
    December 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT # N160001, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACLOFEN OVERDOSE DUE TO A PRIMING BOLUS PROGRAMMING ERROR. A DYE STUDY WAS DONE ON THE CATHETER PRIOR TO SCHEDULING THE PATIENT FOR A PUMP REPLACEMENT SURGERY. FOLLOWING THE DYE STUDY, AND INCORRECT PRIMING BOLUS WAS PROGRAMMED. THE PHYSICIAN DESCRIBED GIVING A 3000 MCG BOLUS OVER AN HOUR. BY THE TIME THE PATIENT RETURNED HOME, THE PATIENT WAS FEELING WEAK AND LIGHT-HEADED, SO THE PATIENT WAS TAKEN TO THE CLOSEST ER (EMERGENCY ROOM). THE PATIENT HAD ADDITIONAL SYMPTOMS OF AN ALTERED MENTAL STATUS, SLEEPINESS, AND AN EVENTUAL NEED FOR ARTIFICIAL VENTILATION. THE ER PHYSICIAN TURNED THE PUMP DOWN TO MINIMUM RATE. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT REQUIRED INTUBATION/VENTILATION AND WAS IN THE ICU (INTENSIVE CARE UNIT). THE NEXT DAY ON (B)(6) 2013, THE ICU PHYSICIAN TURNED THE PUMP BACK UP TO THE ORIGINAL SETTINGS OF FLEX DOSING 525 MCG/DAY. THE PATIENT REMAINED ORALLY INTUBATED TO MAINTAIN OXYGENATION. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE-WITH INJURY.¿ IT WAS DETERMINED BY THE PUMP MANAGING PHYSICIAN THAT THERE WAS AN INCORRECT PRIMING BOLUS THAT WAS DELIVERED. THE PUMP WAS DELIVERING LIORESAL (2000 MCG/ML). IT WAS LATER REPORTED THAT THE INTENDED BOLUS WAS 0.157ML OF 2000 MCG/ML LIORESAL. IT WAS LATER REPORTED THAT THE PATIENT WAS DOING WELL FOLLOWING THE EVENT AND HAD RETURNED HOME FROM THE HOSPITAL WITHOUT ANY ADDITIONAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43583 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| L| R