BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3100398 · Received May 8, 2013

    Report

    Report Number
    1416980-2013-11722
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE PATIENT AT-HOME GUIDE, USERS ARE INSTRUCTED TO PLACE THE SOLUTION BAGS ON A FLAT, STABLE SURFACE. TO PREVENT BAGS FROM FALLING, DO NOT STACK BAGS ON TOP OF EACH OTHER. FALLING BAGS CAN RESULT IN A DISCONNECT OR LEAK. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. A SUPPLY BAG HAD FALLEN AND DISCONNECTED. THE HOME PATIENT (HP) WOULD COMPLETE THERAPY USING MANUAL EXCHANGES. 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
    201899 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR HOMECHOICE