BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2083520 · Received May 10, 2011

    Report

    Report Number
    1423500-2011-05706
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RECEIVED FOR EVALUATION AT THE PRODUCT ANALYSIS LAB (PAL). THE RETURN INSTRUMENT TEST / EVALUATION (RITE) FAILURE DUE TO GROUND BOND FAILED PERFORMANCE SPECIFICATION IS AUTOMATICALLY CONFIRMED, HOWEVER DUE TO THE NATURE OF THE FAILURE, WOULD NOT BE RECORDED IN THE DEVICE LOGS. A CONTINUITY TEST BETWEEN THE POWER ENTRY MODULE AND THE DOOR POST GROUND REVEALED THE GROUND BUS WAS OUT OF SPECIFICATION. THE SETSCREW ON THE DOOR POST WAS TIGHTENED AND THE GROUND BUS RESISTANCE MEASURED WITHIN THE GROUND BOND SPECIFICATION. THE CAUSE FOR RITE TEST FAILURE - GROUND BOND WAS DETERMINED TO BE A LOOSE SETSCREW ON THE DOOR POST. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE RITE FAILURE. THE DOOR POST WAS IDENTIFIED TO BE SCRAPPED DURING SERVICING. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO THE GROUND BOND TEST INDICATING A HIGH RESISTANCE VALUE BETWEEN THE HC AND THE GROUND BOND ON THE POWER SUPPLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1