BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PD NXD DISPOSABLE EXTENSION LINE

    MDR report key: 259831 · Received January 19, 2000

    Report

    Report Number
    1423500-2000-00144
    Event Type
    Malfunction
    Date Received
    January 19, 2000
    Date of Event
    January 1, 2000
    Report Date
    January 18, 2000
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOME PATIENT (HP) REPORTS QUANTUM EXTENSION LINE TUBING BECAME DISCONNECTED FROM THE ULTRABAG PT CONNECTOR DURING EXCHANGE AND FLUID LEAKED ONTO FLOOR. PER HP, NOTHING UNUSUAL WAS NOTED WITH CONNECTION AT TIME OF THERAPY SET UP. HP DISCONTINUED TREATMENT AND REPORTS NO INJURY OR MEDICAL INTERVENTION AS A RESULT OF INCIDENT.

    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 H98H28585

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ULTRABAG