BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3162416 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-14972
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) HAD RECEIVED A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) THAT OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING DRAIN 4 OF 7. THE PATIENT WAS CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND POSSIBLE CAUSES. THE HP STATED THEY DID MANUAL SUPPLIES TO COMPLETE THE THERAPY. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262833 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR HOMECHOICE