BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMODIALYSIS CATHETER

    MDR report key: 3854180 · Received June 5, 2014

    Report

    Report Number
    MW5036461
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    December 15, 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

    ON (B)(6) 2012, THE PT WAS IMPLANTED WITH A HEMODIALYSIS CATHETER IN HIS CHEST. ON (B)(6) 2012, HE WENT TO THE DIALYSIS CENTER FOR HIS TREATMENT. AFTER TREATMENT, HE WAS DISCONNECTED FROM THE MACHINE AND HE COMPLAINED OF CHEST PAIN, BUT WAS DISCHARGED BY THE PCT. IN THE EARLY MORNING OF (B)(6) 2012, RPTR (MOTHER) FOUND THE PT ON THE FLOOR DECEASED. RPTR CONTACTED THE USER FACILITY TO LAY A COMPLAINT AND ASK FOR AN AUTOPSY BUT HER REQUEST WAS REFUSED. SHE ORDERED A PRIVATE AUTOPSY AND IT WAS DETERMINED THAT THE CATHETER PIERCED HER SON'S HEART DURING TREATMENT AND HE BLEED TO DEATH. RPTR CONTACTED BARD THE MFR AND SPOKE TO (B)(4) BUT THE ISSUE WAS NOT RESOLVED. THE USER FACILITY REFUSED TO RELEASE ANY INFO ABOUT THE CATHETER OR MEDICAL RECORDS OF THE PT TO THE RPTR (MOTHER) OR THE MFR FOR FURTHER RESEARCH. USER FACILITY NAME: (B)(6). DIALYSIS CENTER: (B)(6). THE RPTR IS LAYING THIS COMPLAINT BECAUSE OF THE USER FACILITY'S FAILURE TO REPORT THIS INCIDENT TO THE MFR AND FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328459 HEMODIALYSIS CATHETER NONE MSD BARD 19

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death