BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2160940 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-04502
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL WAS HAVING DIFFICULTY ACCESSING THE CENTER PORT AT REFILL. THE REPORTER BELIEVED THAT THEY WERE IN THE SEPTUM, BUT EXPECTED 33ML'S AND WAS NOT GETTING ANYTHING BACK. THE HCP USED "FLURO" TO CONFIRM NEEDLE ACCESS AND CONFIRMED THE PUMP WAS EMPTY WITH SALINE FILL. A BRIDGE BOLUS OF 478 MCG WAS USED AS THE DRUG CONCENTRATION WAS CHANGED FROM 1000 TO 500 MCG/ML. THE DAILY DOSE REMAINED CONSTANT AT 149.9 MCG/DAY. THE PT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT AND RECOVERED WITHOUT SEQUELA. NO SYMPTOMS WERE REPORTED. IF ADDITIONAL INFO BECOMES AVAILABLE ABOUT THIS EVENT, IT WILL BE REPORTED ON A FOLLOW-UP.

    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 43 YR CATHETER: MODEL 8731SC, LOT# N224503005| IMPLANTED:| EXPLANTED: