BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 4021395 · Received August 19, 2014

    Report

    Report Number
    1416980-2014-27221
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Report Date
    July 28, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - FAILED TO FOLLOW THERAPY STEPS, WHERE THE HOME PATIENT CONNECTED SUPPLY BAGS AND THEMSELVES THE HOMECHOICE (HC) MACHINE PRIOR TO HC SELF-TESTING. 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 INSTRUCTS THE USER TO CONNECT THE SOLUTION BAGS AFTER THE SELF-TEST. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT CONNECTED SUPPLY BAGS AND THEMSELVES TO THE HOMECHOICE (HC) MACHINE PRIOR TO HC SELF-TESTING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497641 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE