BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PD NXD DISPOSABLE EXTENSION LINE

    MDR report key: 261801 · Received February 9, 2000

    Report

    Report Number
    1423500-2000-00207
    Event Type
    Malfunction
    Date Received
    February 9, 2000
    Date of Event
    February 1, 2000
    Report Date
    February 7, 2000
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOME PATIENT (HP) REPORTS FLUID LEAKING FROM CONNECTION OF THE QUANTUM EXTENSION LINE TO THE ULTRABAG PT CONNECTOR WHEN PT AWOKE IN THE MORNING POST EXCHANGE. HP REPORTS NO INJURY OR MEDICAL INTERVENTION AS A RESULT OF INCIDENT. HP ALSO STATES CONNECTION WAS SECURE AT THERAPY SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM PD NXD DISPOSABLE EXTENSION LINE NXD EXTENSION LINE FKX BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ULTRABAG