BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 360242 · Received November 16, 2001

    Report

    Report Number
    1056436-2001-00159
    Event Type
    Injury
    Date Received
    November 16, 2001
    Date of Event
    September 1, 2001
    Report Date
    November 16, 2001
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2001, A FAXED REPORT WAS REC'D FROM THE MFR'S CHAIRMAN AND CEO. THE MFR'S CHAIRMEN AND CEO REC'D A LETTER FROM A PT 6 DAYS BEFORE THAT STATES THE FOLLOWING: A CANCER PT IN A USER FACILITY. THIS JUNE AN ACCESS DEVICE MFG BY THE CO WAS SURGICALLY IMPLANTED IN PT'S CHEST. ON THE MONTH OF THE EVENT, A SHARP METAL RING ON THE CO'S ACCESS DEVICE RIPPED A HOLE IN PT'S SKIN FROM THE INSIDE. THIS OPEN WOUND GAVE PT A LIFE THREATENING INFECTION IN THE MIDDLE OF PT'S CHEMOTHERAPY TREATMENT. PT HAD TO HAVE TEN DAYS OF MULTIPLE ANTIBIOTIC TREATMENT INCLUDING VANCOMYCIN, CEFTIAXONE AND CIPRO. THE DEFECTIVE ACCESS DEVICE WAS REPLACED WITH ANOTHER ONE FROM THE CO. AFTER THE ACCESS DEVICE WAS REPLACED, PT'S CHEMOTHERAPY TREATMENT CONTINUED WITH 48 HOURS OF CONTINUOUS INFUSION OF DOXORUBICIN. AFTER THE TREATMENT, AN AREA NEAR THE BOTTOM OF PT'S NECK ON THE SAME SIDE AS IMPLANTED ACCESS DEVICE STARTED TO SWELL AND TURNED TENDER AND RED. THE CONDITION IN THE AREA DETERIORATED OVER THE NEXT SEVERAL WEEKS. FINALLY A DYE STUDY OF THE SECOND ACCESS DEVICE WAS PERFORMED. THE STUDY FOUND ONE OF THE TWO WELLS WAS LEAKING FROM THE SIDE OF THE DEVICE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51895 LIFEPORT VASCULAR ACCESS SYSTEM VASCULAR ACCESS DEVICE LJT HORIZON MEDICAL PRODUCTS, INC. NA 15428

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention