BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3241156 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19313
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 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). THIS COMPLAINT IS FOR A SYSTEM ERROR 2240 DURING THE DWELL STAGE, WHERE THE HOME PATIENT HAD 2 BAGS CONNECTED AND THE UNUSED LINE CLAMPS WERE OPEN. THIS COMPLAINT IS CONFIRMED BECAUSE LEAVING A CLAMP OPEN ON AN UNUSED SUPPLY LINE IS A USE ERROR THAT MAY CAUSE A SYSTEM ERROR 2240 AND CONTAMINATION. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE" WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE WARNS THE USER TO MAKE SURE ALL CLAMPS ON UNUSED FLUID LINES ARE CLOSED SECURELY, INSTRUCTS THE USER TO CLOSE ALL CLAMPS WHILE PREPARING TO LOAD THE DISPOSABLE SET, AND WARNS THE USER THAT A SYSTEM ERROR 2240 CAN BE CAUSED BY UNCLAMPED, UNUSED SUPPLY LINES. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN SET), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 3 OF 4, WHILE THE PATIENT WAS CONNECTED. THE HOME PATIENT (HP) HAD 2 BAGS CONNECTED AND THE UNUSED LINE CLAMPS WERE OPEN. THEY CYCLED POWER AND RECEIVED SE 2367 THE HP WOULD COMPLETE THERAPY WITH MANUAL BAGS. THE SAMPLES ARE UNAVAILABLE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341753 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HOMECHOICE