BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3033828 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08327
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    January 18, 2013
    Report Date
    March 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING EVALUATION OF A HOMECHOICE HARDWARE DEVICE AN ALARM, INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE, WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. THEREFORE THE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A SYSTEM ERROR 2240 (AIR IN LINE) ALARM WAS IDENTIFIED. THE ALARM WAS FOUND IN THE LOG, WHICH INDICATES A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE. THE ALARM OCCURRED DURING THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136212 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE