BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1853259 · Received October 5, 2010

    Report

    Report Number
    1423500-2010-04050
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 8, 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 RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. THE RITE (RETURN INSTRUMENT TEST/EVALUATION) TEST WAS PERFORMED WHEN THE DEVICE WAS RETURNED TO THE BAXTER TAMPA BAY FACILITY FOR EVALUATION. THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION) FUNCTIONAL TEST FOR THE DISPLAY GOING BLANK DURING THE TILT TEST AND FAILED THE ELECTRICAL EARTH LEAKAGE TEST. RESISTANCE MEASUREMENTS REVEALED THE PUMP WAS SHORTED LIKELY DUE TO MOISTURE/FLUID WITHIN THE PUMP AND PNEUMATIC SYSTEM. THE ASSIGNABLE CAUSE FOR RITE TEST FAILURE ? EARTH LEAKAGE CURRENT WAS DETERMINED TO BE A SHORTED PUMP. A REVIEW OF THE SERVICE HISTORY RECORD REVEALED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUES, RITE FAILURES OR THE FLUID IN THE PNEUMATIC SYSTEM. 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

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO AN EARTH LEAKAGE; CURRENT FAILED TO MEET SPECIFICATION.

    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