BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SE PUMP ADMINISTRATION SET

    MDR report key: 1812600 · Received August 18, 2010

    Report

    Report Number
    9616066-2010-00240
    Event Type
    Death
    Date Received
    August 18, 2010
    Date of Event
    June 3, 2010
    Report Date
    July 19, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED: FACILITY REPORTER INDICATED THERE WAS NO PRODUCT TO RETURN. THE LOT NUMBER WAS IDENTIFIED. THE MANUFACTURING DATABASE WAS REVIEWED; NO QUALITY ISSUES WERE NOTED DURING PRODUCTION BUILD FOR THE INVOLVED LOT NUMBER.

    Description of Event or Problem · 1

    CUSTOMER FACILITY MEDWATCH REPORT RECEIVED THAT STATES "DEATH FOLLOWING ADMINISTRATION OF TUBE FEEDING THROUGH IV SITE. FEED TUBING AND IV TUBING SHARE SAME DIAMETER AND SHARE COMPATIBLE CONNECTION. IV TUBING WAS CONNECTED TO FEEDING BAG. TUBING WAS CONNECTED TO IV PUMP". FACILITY REPORTER INDICATED, THE EVENT WAS NOT CONSIDERED A PRODUCT ISSUE, WHEN TUBING IS USED APPROPRIATELY, IT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE PUMP ADMINISTRATION SET FPA CAREFUSION CORPORATION 72023E 10025866

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death ALARIS SE GOLD PUMP MODEL 7230, SERIAL # UNK.