BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3111859 · Received May 14, 2013

    Report

    Report Number
    1416980-2013-12280
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. USERS ARE WARNED NOT TO RECONNECT DISCONNECTED SOLUTION BAGS DURING PERITONEAL DIALYSIS THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE HOME PATIENT FIRST STARTED THE CYCLER, THE BAG WOULD NOT DRAIN OR FILL. THE PATIENT DID NOT HAVE ANY ADDITIONAL INFORMATION. THE PATIENT CHANGED BAGS AND THE ISSUE WAS RESOLVED. THE PATIENT WAS CONNECTED. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212696 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE