BEUDAMED
    FDA Adverse Event Death Summary report: N

    CATHETER

    MDR report key: 3870123 · Received June 6, 2014

    Report

    Report Number
    MW5036528
    Event Type
    Death
    Date Received
    June 6, 2014
    Date of Event
    December 17, 2012
    Report Date
    June 5, 2014
    Manufacturer
    BARD
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SON (B)(6) A DIALYSIS PT HAD A HEMODIALYSIS CATHETER IMPLANTED IN HIS HEART ON (B)(6) 2012. (B)(6) WAS FOUND BY ME, DECEASED. HIS DEATH WAS UNEXPECTED AND UNATTENDED. HIS DEATH WAS PREVENTABLE. PER AUTOPSY REPORT THE CATHETER PIERCED A HOLE IN HIS HEART AND WAS THE DIRECT CAUSE OF HIS DEATH. THE USER FACILITY CLINIC THAT IMPLANTED THE CATHETER HAS FAILED TO REPORT THIS INCIDENT OF DEATH TO THE MFR AND THE FDA. ON (B)(6) 2012, AT 4PM AN UNLICENSED, NON CERTIFIED PCT (TRAINEE) DISCONNECTED THE CATHETER FROM THE DIALYSIS MACHINE (B)(6) EXPERIENCED A SUDDEN PAIN IN HIS CHEST. (B)(6) INFORMED THEM OF THE PAIN. THEY DISCHARGED (B)(6) TO GO HOME, SAYING THAT HE WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332412 CATHETER CATHETER, HEMODIALYSIS, IMPLANTED MSD BARD

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death