BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1971633 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01104
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    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). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DISCONTINUED USE OF THE HOMECHOICE DUE TO RECEIVING A TRANSPLANT AND RETURNED THE DEVICE TO THE (B)(4) FACILITY. 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 RESISTANCE READING FROM THE DOOR FRAME TO THE DOOR POST WAS FOUND TO BE OUT OF SPECIFICATION. THE DOOR POST SCREW WAS THEN SLIGHTLY TIGHTENED AND THE RESISTANCE WAS WITHIN THE GROUND BOND SPECIFICATION. THE ASSIGNABLE CAUSE FOR RITE TEST FAILURE - GROUND BOND WAS DETERMINED TO BE THE DOOR POST FIXING SCREW WAS NOT TIGHT ENOUGH. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE RITE FAILURE. 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 EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE GROUND BOND TEST INDICATING A HIGH RESISTANCE VALUE BETWEEN THE HC AND THE GROUND BOND ON THE POWER SUPPLY.

    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 49 YR