BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3093337 · Received May 6, 2013

    Report

    Report Number
    1416980-2013-11351
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A LABELING REVIEW FOUND THAT ALL PRINTED POUCHES FOR DISPOSABLE PRODUCTS INTENDED FOR SINGLE USE ARE LABELED WITH "THIS DEVICE IS INTENDED FOR SINGLE USE ONLY". A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICES CENTER REGARDING AN ALARM, WHICH OCCURRED ON THE HOME CHOICE (HC) DURING DWELL 1. THE HOME PATIENT (HP) STATED THAT WHEN ALARM OCCURRED SHE DISCONNECTED SUPPLY BAG, CONNECTED A NEW BAG AND COMPLETED THERAPY. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED HP NOT TO DISCONNECT/RECONNECT BAGS. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196523 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HOME CHOICE