BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1901002 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05838
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE EVALUATION IS IN PROGRESS, BUT NOT YET COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE HOMECHOICE (HC) WAS EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE HC PASSED FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS, PER RETURNED INSTRUMENT TEST/EVALUATION (RITE) TESTING. NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL (IIPV) FOUND IN THE DEVICE LOG. THE ASSIGNABLE CAUSE OF THE IIPV WAS DETERMINED TO BE AN INSUFFICIENT DRAIN-ONE OR MORE CYCLES ADVANCING TO THE NEXT FILL WHEN A SLOW/NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD & FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATELY SET INITIAL DRAIN TIME, NIGHT DRAIN TIME TOO LOW (1 MIN). REVIEW OF THE SERVICE HISTORY SHOWS THE HC PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM BAXTER. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPV. THE PREVIOUS RETURN OF THE HC WAS NOT FOR ANY ISSUES RELATED TO THE IIPV. A LABELING REVIEW WAS PERFORMED AND FOUND THE LABELING SUFFICIENT. THE HOMECHOICE APD SYSTEMS AT HOME GUIDE AND TRAINER'S GUIDE OUTLINE METHODS TO AVOID THE OCCURRENCE OF IIPV. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    AN INSTANCE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED DURING A REVIEW OF THE RETURNED HOMECHOICE (HC) PATIENT EVENT LOG. ON (B)(6) 2010, THE DRAIN VOLUME WAS 864ML DURING CYCLE 2. PRODUCT SURVEILLANCE SPOKE WITH THE PATIENT'S MOTHER WHO STATED, SHE HAD NOT NOTED ANY LARGE DRAIN VOLUMES AND HER SON WAS DOING WELL. THE PATIENT'S MOTHER CONFIRMED, HER SON DID NOT SHOW SIGNS OF ANY DISCOMFORT. THE MOM STATED, SINCE THE MACHINE HAS BEEN SWAPPED THERE HAS BEEN NO ALARMS OR ANY OTHER ISSUES WITH THERAPY. THE MOM STATED, HER SON WAS JUST SEEN BY THE DOCTOR FOR A CHECK UP AND EVERYTHING WAS GOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR