BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMODIALYSIS TWO-LUMEN KIT: 2-

    MDR report key: 598975 · Received May 3, 2005

    Report

    Report Number
    1036844-2005-00024
    Event Type
    Death
    Date Received
    May 3, 2005
    Date of Event
    April 11, 2005
    Report Date
    April 26, 2005
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CANNON CATHETER WAS SUCCESSFULLY PLACED AND THE PT WAS TRANSFERRED TO ICU. IN ICU, AN AIR EMBOLISM WAS NOTICED AND THE CLINICIAN WAS CALLED IN. HE UTILIZED A SYRINGE TO "EXTRACT AIR". HE LATER DISASSEMBLED THE HUB AND DISCOVERED THE GREEN COMPRESSION SLEEVE FITTING HAD NOT BEEN PLACED. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYSIS TWO-LUMEN KIT: 2- CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTL., INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death