BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3190608 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16450
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW FOUND THAT ALL PRINTED POUCHES FOR DISPOSABLE PRODUCTS INTENDED FOR SINGLE USE ARE LABELED WITH THE STATEMENT, "THIS DEVICE IS INTENDED FOR SINGLE USE ONLY". A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY ADDITIONAL RELEVANT INFORMATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT CHANGED THE HEATER BAG WITHOUT CHANGING THE 3-PRONG AUTOMATED PD SET WITH CASSETTE; THUS, REUSING A SINGLE-USE PRODUCT IN ORDER TO RESOLVE AN UNRELATED ALARM ON THE HOMECHOICE (HC) DURING PERITONEAL DIALYSIS (PD) THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE PATIENT TO END THERAPY AND INSTRUCTED THE PATIENT TO NEVER CHANGE BAGS DURING THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290039 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR HOMECHOICE