BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2142506 · Received June 28, 2011

    Report

    Report Number
    1423500-2011-08442
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 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 PASSED THE HOMECHOICE RITE FUNCTIONAL TEST. THE HOMECHOICE RITE ELECTRICAL TEST FAILED TESTING. AN INSPECTION WAS PERFORMED ON THE DOOR POST. THIS INSPECTION REVEALED THE DOOR POST SCREW WAS LOOSE. THE SCREW WAS TIGHTENED AND MAIN GROUND BUS WAS MEASURED. THE READING IS 0.01 OHMS BETWEEN DOOR POST TO POWER ENTRY MODULE AND ALL OTHERS GROUND RESISTANCE WERE IN SPECIFICATIONS. FOR THE RITE FAILURE OF GROUND BOND RESISTANCE, THE ASSIGNABLE CAUSE WAS DETERMINED TO BE LOOSE SCREW ON THE DOOR POST. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    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.

    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 THE DEVICE 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 PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1