BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 508240 · Received January 28, 2004

    Report

    Report Number
    1056436-2004-00001
    Event Type
    Injury
    Date Received
    January 28, 2004
    Date of Event
    December 27, 2003
    Report Date
    January 28, 2004
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH A HISTORY OF MULTIPLE MYELOMA HAD A PORT PLACED IN 2003 FOR CHEMOTHERAPY. PT DID WELL UNTIL RECENTLY WHEN THEY NOTED LEAKAGE AT THE NEEDLE SITES DURING PORT ACCESS. AN ANGIOGRAM DONE 3 MONTHS LATER REVEALED POOLING OF CONTRAST AROUND THE CHEST PORT, SUGGESTING A POSSIBLE LEAK AT THE SITE OF CONNECTION. THE PT WAS TAKEN TO SURGERY THE FOLLOWING DAY FOR REMOVAL AND REPLACEMENT OF THE PORT. THEY TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM VASCULAR ACCESSPORT LJT HORIZON MEDICAL PRODUCTS, INC. NA 16768

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention