BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3023953 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07487
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    September 26, 2012
    Report Date
    March 9, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING EVALUATION OF A HOMECHOICE HARDWARE DEVICE THE ALARM WAS CONFIRMED THROUGH THE EVENT HISTORY LOG REVIEW . THIS ALARM IS INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS OF THE CASSETTE CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A SYSTEM ERROR 2240 ALARM (AIR IN LINE) WAS IDENTIFIED IN THE LOG, WHICH INDICATES A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE. THE ALARM OCCURRED ON (B)(6) 2012 AT 01:47:42. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125838 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE