BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD ACCESS SYSTEM

    MDR report key: 1878077 · Received October 13, 2010

    Report

    Report Number
    1878077
    Event Type
    Death
    Date Received
    October 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BARD ACCESS SYSTEMS, INC
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TAKEN TO THE OPERATING ROOM FOR PLACEMENT OF A CENTRAL LINE FOR CHEMOTHERAPY ADMINISTRATION. PROCEDURE WENT WELL, BUT ON REVIEW OF FINAL IMAGE WITH CONTRAST DID NOT REVEAL THAT THE LINE WAS IN THE RIGHT ATRIUM. THE LINE WAS REMOVED TO BE REPLACED AND THE PT EXPERIENCED PULSE-LESS ELECTRICAL ACTIVITY AND ARRESTED. CPR WAS PERFORMED WITH OPEN HEART MASSAGE. WHEN A PULSE RETURNED A HOLE WAS IDENTIFIED IN THE SUPERIOR VENA CAVA (SVC). THIS HOLE WAS CLOSED AND THE PT WAS MOVED TO THE ICU. THE PT WAS MANAGED IN THE ICU UNTIL HIS DEATH FROM INFECTION ON (B)(6)2010. AFTER A REVIEW AND DISCUSSION OF THIS CASE ON (B)(6)2010, IT WAS IDENTIFIED THAT THE LINE INTRODUCER WAS A LITTLE INFLEXIBLE AND MAY HAVE CONTRIBUTED TO THE SVC INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEM HICKMAN 9.0 FRENCH DUAL LUMAN CATHETER LJT BARD ACCESS SYSTEMS, INC 0600600 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Death