BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4771714 · Received May 14, 2015

    Report

    Report Number
    1416980-2015-21364
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    March 25, 2015
    Report Date
    April 24, 2015
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING EVALUATION OF A RETURNED 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 WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED AND A CAUSE WAS NOT FOUND. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A SYSTEM ERROR 2240 ALARM (AIR IN LINE/SET) WAS IDENTIFIED IN THE LOG WHICH INDICATES A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE. THE ALARM OCCURRED ON (B)(6) 2015 AT 08:00:36. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316839 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE