BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1861405 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04161
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP E MDR.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL TEST BUT FAILED THE RITE ELECTRICAL GROUND BOND TEST. THE PAL (PRODUCT ANALYSIS LAB) EVALUATED THE DEVICE. THE DEVICE WAS POWER CYCLED SEVERAL TIMES WITH NO PROBLEMS ENCOUNTERED. AN INTERNAL INSPECTION REVEALED NO ISSUES. THE ASSIGNABLE CAUSE FOR RITE TEST FAILURE - GROUND BOND, WHICH IS A REPORTABLE MALFUNCTION, WAS DETERMINED TO BE A LOOSE SET SCREW ON THE DOOR POST. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER DISCONTINUED USE OF THE HOMECHOICE (HC) MACHINE AND RETURNED IT TO BAXTER. DURING INITIAL ASSESSMENT OF THE RETURNED MACHINE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO A GROUND BOND FAILED PERFORMANCE SPECIFICATIONS. FOLLOW UP REVEALED THAT THE CUSTOMER DISCONTINUED USE OF THE DEVICE BECAUSE THEY WERE TRANSFERRED TO HEMODIALYSIS.

    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 79 YR