BEUDAMED
    FDA Adverse Event Death Summary report: N

    MODEL 3000 ML MED FLOW PUMP

    MDR report key: 527967 · Received June 2, 2004

    Report

    Report Number
    1226348-2004-00166
    Event Type
    Death
    Date Received
    June 2, 2004
    Date of Event
    May 6, 2004
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    LKK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REFILL OF THE IMPLANTED PUMP, THE PT FELT PROGRESSIVE AND PRONOUNCED NUMBNESS IN LOWER EXTREMITIES. THIS APPEARED TO HAVE STARTED IMMEDIATELY FOLLOWING THE SALINE FLUSH STEP OF THE REFILLING OPERATION AND BECAME WORSE AFTER INJECTION OF THE MEDICATIONS INTO THE PUMP. ONE DAY LATER THE PT WAS REPORTED TO BE "BRAIN-DEAD." IT WAS LEARNED IN 2004, THAT THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 3000 ML MED FLOW PUMP PUMP,INFUSION,IMPLANTED, PROGRAMMABLE LKK CODMAN & SHURTLEFF, INC. NA 10585

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death