BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2180309 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09790
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 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 DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. THE CAUSE OF THE RITE EARTH LEAKAGE CURRENT FAILED PERFORMANCE SPEC WAS DETERMINED TO BE BLOWN FUSES CAUSED BY THE SHORTED PUMP ASSEMBLY. 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.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: 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 A FAILURE OF THE EARTH LEAKAGE CURRENT TEST.

    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 DEVICE FAILED THE FLUID TEMPERATURE DELIVERY VERIFICATION STEP. 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