BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3172692 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15530
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE CONNECTION BETWEEN THE LINE AND ONE OF THE BAGS WAS LOOSE. A LOOSE CONNECTION CAN CAUSE AN SYSTEM ERROR 2240. HOWEVER THE CAUSE OF THE LOOSE CONNECTION COULD NOT BE DETERMINED, AS THE CASSETTE WAS NOT RETURNED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) HAD RECEIVED A SYSTEM ERROR 2240 (AIR IN SET) ALARM. THIS HAD OCCURRED ON A HOMECHOICE (HC) MACHINE DURING DWELL FIVE OF SEVEN. THE HP CHECKED THE LINES AND BAGS AND FOUND THAT THE CONNECTION ON THE SECOND SUPPLY BAG WAS LOOSE AND LEAKING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP IN CLEARING THE ALARM AND IN ENDING THERAPY. THERE WAS NO ADVERSE EVENT INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273489 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE