BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3053367 · Received April 11, 2013

    Report

    Report Number
    1416980-2013-09044
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM ERROR 2240 ALARM WAS FOUND TO HAVE AN UNDETERMINED CAUSE. THE PROBLEM CANNOT BE CONFIRMED DUE TO NO USE ERROR DESCRIBED BY THE PATIENT, THE SAMPLE AND LOT NUMBER WERE UNAVAILABLE FOR EVALUATION AND AN EVENT LOG WAS NOT REVIEWED BY A BAXTER EMPLOYEE. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP 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 INITIAL DRAIN. THE CARE GIVER (CG) STATED THAT THERE APPEARED TO BE A LEAK IN THE TUBING OF THE PATIENT LINE. THE CG WAS WILLING TO SEND THE SAMPLE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO SETUP THE HC WITH ALL NEW DISPOSABLES. THE CG WOULD SETUP WITH ALL NEW SUPPLIES. THE HC WAS OPERATIONAL. 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
    155734 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR HOMECHOICE