BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PD NXD DISPOSABLE EXTENSION LINE

    MDR report key: 259819 · Received January 19, 2000

    Report

    Report Number
    1423500-2000-00136
    Event Type
    Malfunction
    Date Received
    January 19, 2000
    Date of Event
    January 1, 2000
    Report Date
    January 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 PT WAS UNABLE TO TIGHTEN THE CONNECTION OF THE QUANTUM EXTENSION LINE TO THE ULTRABAG PT CONNECTOR AT THERAPY SET UP. HP STATES CONNECTOR KEPT TURNING WHEN TIGHTENED AND NO POSITIVE STOP WAS NOTED. HP DISCARDED SET AND SET UP NEW SUPPLIES TO COMPLETE EXCHANGE. HP REPORTS NO INJURY OR MEDICAL INTERVENTION AS A RESULT OF INCIDIENT.

    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 H99J19325

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ULTRABAG