BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSAID

    MDR report key: 653624 · Received August 17, 2005

    Report

    Report Number
    MW1036377
    Event Type
    Death
    Date Received
    August 17, 2005
    Date of Event
    August 2, 2005
    Report Date
    August 17, 2005
    Manufacturer
    PFIZER
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PUMP INSERTED IN 1994. PUMP HAS BEEN REFILLED APPROX. EVERY 7 WEEKS. PUMP BECAME DIFFICULT TO ACCESS OVER TIME. PT'S INCREASED WEIGHT AND ABDOMINAL TISSUE AROUND THE PUMP MADE IT HARD TO HAVE CODMAN TEMPLATE KIT IDENTIFY THE PUMP. THE REFILL PORT WAS LOCATED BY PALPATION, PUMP WAS ACCESSED WITH SOLUTION RETURNED. PUMP REFILLED WITH MORPHINE. PT COMPLAINED OF TINGLING, AND SEVERE HEADACHE. B/P UP, AND BECAME UNRESPONSIVE. PT WAS RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSAID CONSTANT FLOW PUMP LKK PFIZER 400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death