BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3110577 · Received May 14, 2013

    Report

    Report Number
    1416980-2013-12240
    Event Type
    Malfunction
    Date Received
    May 14, 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. 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

    IT WAS REPORTED TO BAXTER CANADA THAT WHEN THE CUSTOMER FIRST STARTED THE CYCLER, THE BAG WOULD NOT DRAIN OR FILL. THE PATIENT CHANGED BAGS AND THE ISSUE WAS RESOLVED. THE PATIENT WAS CONNECTED. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY. THE DATE OF THE EVENT IS UNKNOWN. THE PATIENT DID NOT HAVE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212285 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE