BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PD NXD DISPOSABLE EXTENSION LINE

    MDR report key: 280029 · Received May 26, 2000

    Report

    Report Number
    1423500-2000-00644
    Event Type
    Malfunction
    Date Received
    May 26, 2000
    Date of Event
    March 28, 2000
    Report Date
    March 28, 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 PT(HP) REPORTS QUANTUM EXTENSION SET WOULD NOT CONNECT SECURELY TO ULTRABAG PT CONNECTOR AT THERAPY SET UP. HP REPORTS CONNECTOR KEPT TURNING AND NEVER REACHED A POSITIVE STOP. HP DID NOT USE AND REPORTS NO INJURY OR MEDICAL INTERVENTION.

    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 H99K08250

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ULTRABAG