BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3163345 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-15027
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    October 26, 2012
    Report Date
    May 17, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A SYSTEM ERROR 2240 (AIR IN LINE) ALARM WAS IDENTIFIED IN THE LOG. THIS INDICATES A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE. THE ALARM OCCURRED ON (B)(6) 2012. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264003 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE