BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PD NXD DISPOSABLE EXTENSION LINE

    MDR report key: 218087 · Received April 5, 1999

    Report

    Report Number
    1423500-1999-00334
    Event Type
    Malfunction
    Date Received
    April 5, 1999
    Date of Event
    March 1, 1999
    Report Date
    March 10, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOME PATIENT REPORTED QUANTUM EXTENSION LINE SEPARATED FROM ULTRABAG DURING DRAIN PHASE OF EXCHANGE. HOME PATIENT REC'D A "LOW FLOW" ALARM AND DISCONTINUED TREATMENT. HOME PATIENT PERFORMED A MANUAL EXCHANGE AND REPORTS NO INJURY OR MEDICAL INTERVENTION. HOME PATIENT DISCARDED SAMPLE AND STATES HE BELIEVES 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 H98K06560*

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN