BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2852790 · Received November 30, 2012

    Report

    Report Number
    1416980-2012-06248
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW AND SERVICE HISTORY REVIEW WERE PERFORMED WITH NO ISSUES FOUND. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE DEVICE WAS NOT RETURNED TO BAXTER, AND THEREFORE SAMPLE EVALUATION WILL NOT BE COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT AN ISSUE OF PROGRAM CHANGED BY DEVICE WHILE ON HOME CHOICE (HC) DEVICE DURING USE. THE HOME PATIENT (HP) HAD PROGRAMMED THE THERAPY SESSION THAT WAS DIFFERENT . THE NURSE STATED THAT THE PROGRAMED VOLUME WAS 4 TIMES 2.2 L OF SOLUTION AND 1.5 L OF EXTRANEAL IN THE LAST FILL. THE TOTAL VOLUME WAS 10.300 IN PDCC (UNKNOWN ABBREVIATION). THE DIALYZE VOLUME FOR MANY DAYS WAS 8.494 L AND OUTFLOW VOLUME WAS 8.296 L WITH 423 INJECTED IN THE LAST FILL. THE HP REPORTED THAT ABOUT 1.2 L OF THE SOLUTION WAS STILL IN THE EXTRANEAL BAG AND THE INITIAL DRAIN VOLUME WAS 1.5 L. THE HP EXPERIENCED OEDEMA AND HAD REQUESTED TO CHANGED THE HC DEVICE. THERE WAS 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
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1