BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2122174 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07528
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACTUAL SAMPLE WAS EVALUATED. THE REPORTED ISSUE OF PROGRAM CHANGES WAS CONFIRMED IN THE DEVICE LOGS BUT NOT DUPLICATED DURING RITE (RETURN INSTRUMENT TEST / EVALUATION) TESTING. THE DEVICE PASSED THE HOMECHOICE RITE, FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. A REVIEW OF THE DEVICE LOGS REVEALED THE OPERATOR WAS BYPASSING DRAIN PHASES RESULTING IN PARTIAL FILLS AND EXCESS SOLUTION AVAILABLE. IT IS NORMAL DEVICE FUNCTION FOR THE NUMBER OF CYCLES REMAINING DURING THERAPY TO BE RECALCULATED. THE DEVICE CALCULATES THE NUMBER OF CYCLES BASED ON CERTAIN PARAMETERS. USAGE OF ADDITIONAL FLUID DURING THERAPY WILL REDUCE THE TOTAL VOLUME AVAILABLE AND MAY REDUCE THE NUMBER OF CYCLES, WHILE ADDITIONAL FLUID AVAILABILITY MAY INCREASE THE NUMBER OF CYCLES. THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUE OF PROGRAM CHANGES WAS UNDETERMINED. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR USE/USER ERROR RELATED TO THIS INCIDENT. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT PROGRAM CHANGES WHICH OCCURRED ON HOME CHOICE (HC) AFTER USE. THE CUSTOMER STATED THAT THERAPY HAS BEEN CHANGING NIGHTLY. THE REGISTERED NURSE (RN) WILL GIVE HOME PATIENT A NEW CARD AND LOCK THE PROGRAM. THE MACHINE IS BEING SWAPPED. THERE WAS PATIENT INVOLVEMENT. 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 70 YR