BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHERESE FLOW CENTRAL LINE

    MDR report key: 514235 · Received February 24, 2004

    Report

    Report Number
    MW1031287
    Event Type
    Malfunction
    Date Received
    February 24, 2004
    Date of Event
    January 1, 2004
    Report Date
    February 14, 2004
    Manufacturer
    HORIZON MEDICAL PRODUCTS INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT HERE FOR BMT. PT STATED "IT REALLY HURTS RIGHT HERE" (POINTING TO RIGHT SUBCLAVIAN AREA WHERE THE CENTRAL LINE WAS INSERTED). FURTHER STATED "I THINK I'M HAVING AN ALLERGIC REACTION TO THE TAPE ON THIS DRESSING." NURSE PULLED BACK THE TAPE AND DRESSING AND DISCOVERED THAT THE CENTRAL LINE WAS COMPLETELY OUT OF THE PT. NURSE TURNED OFF THE IV PUMPS THAT WERE ATTACHED TO THE CENTRAL LINE AND PUT A CLEAN DRESSING AT THE INSERTION SITE AFTER INSPECTING THE SITE FOR EXTRAVASATION. UPON INSPECTION OF THE CATHETER, NOTED THAT IT WAS NO WHERE TO BE FOUND ON OR NEAR THE PT, ASSUMED THAT IT COULD POSSIBLY BE LODGED INSIDE THE PT. DR ORDERED A STAT CXR. CXR WAS TAKEN AND A PERIPHERAL ACCESS WAS INITIATED IN ORDER TO CONTINUE IV MED ADMINISTRATION. FOLLOW-UP ON THE CXR DID NOT SHOW ANY SIGNS OF THE CATHETER TIP IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHERESE FLOW CENTRAL LINE PHERESE FLOW DQO HORIZON MEDICAL PRODUCTS INC. PHERESE FLOW NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *