BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PD NXD DISPOSABLE EXTENSION LINE

    MDR report key: 239703 · Received September 7, 1999

    Report

    Report Number
    1423500-1999-01103
    Event Type
    Malfunction
    Date Received
    September 7, 1999
    Date of Event
    August 11, 1999
    Report Date
    August 12, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOME PT(HP) REPORTS FLUID APPEARED TO BE LEAKING FROM CONNECTION OF QUANTUM EXTENSION LINE TO ULTRABAG. HP NOTED THREADS APPEARED TO JUMP AT THERAPY SET UP. HP WAS ABLE TO TWIST CONNECTION AFTER POSITIVE STOP. LATER THAT SAME NIGHT, HP REPORTS ROLLING OVER AND EXTENSION LINE SEPARATED FROM ULTRABAG. EFFLUENT LEAKED ONTO PT'S CARPET. HP THEN DISCONTINUED TREATMENT AND DID A MANUAL FILL. HP 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 H99E25339

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 1. ULTRABAG.