BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHERES-FLOW CENTRAL VENOUS CATHETER

    MDR report key: 272510 · Received April 6, 2000

    Report

    Report Number
    1056436-2000-00065
    Event Type
    Injury
    Date Received
    April 6, 2000
    Date of Event
    February 21, 2000
    Report Date
    March 9, 2000
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    FJS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 03/09/2000, THE MFR RECEIVED A REPORT VIA A FAX FROM THE FACILITY THAT STATES THE FOLLOWING: THE DEVICE WAS PLACED IN 2000, VIA RIGHT INTERNAL JUGULAR HEPARIN 5,000 UNITS/CC (RED-1.6, BLUE=1.4, WHITE=1.2). CHANGED DAILY USING STERILE TECHNIQUE VALVES CHANGES AND TEGADERM DRESSING CHANGED 02/01-02/04/2000. THEN EVERY THREE DAYS 02/07, 02/10 AND 02/12/2000. ON 02/13/2000, TEMPERATURE=99.4, COLLECTED 02/14, 02/15 AND 02/16/2000. ON 02/20/2000, FLUSHED, LAB AND VALVE CHANGED. ADMITTED ON 02/21/2000 WITH FEVER/CHILLS. CULTURES OF EACH OF THE THREE LUMENS GREW COAG. NEG. STAPH EPI. AS DID ONE BAG OF COLLECTED STEM CELLS. VANOCOMYCIN X 10 DAYS. COAG. NEG. STAPH CATHETER REMOVED AND CULTURED IN 2000. STARTED ON GRANULOCYTE COLONY-STIMULATING FACTOR FOR RE-HARVEST, 03/07, 03/08, AND 03/09/2000. A TEMPORARY CATHETER WAS PLACED IN THE RIGHT GROIN ON 03/06/2000, THEN WILL NEED PICC LINE PLACED FOR STEM CELL TRANSPLANT. UNABLE TO RETRIEVE DEVICE FROM OPERATING ROOM. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHERES-FLOW CENTRAL VENOUS CATHETER CHRONIC SILICONE CATHETER FJS NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention