BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2132773 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07768
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 25, 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 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). RITE ELECTRICAL TEST FAILED GROUND BOND RESISTANCE TEST (MEASURED 99.000 OHM; ALLOWABLE RANGE .001 TO .100 OHMS): CONFIRMED BY REVIEW OF THE RITE ELECTRICAL TEST REPORT AND DUPLICATED. ASSIGNABLE CAUSE WAS DETERMINED TO BE CAUSED BY THE GROUND WIRE FROM THE DOOR ASSEMBLY WAS NOT CONNECTED TO THE GROUND POST CONNECTION INSIDE THE DEVICE. FOUND WHILE TROUBLESHOOTING THE DEVICE. THE GROUND WIRE CONNECTION FOR THE DOOR ASSEMBLY WILL BE CONNECTED DURING SERVICING.

    Description of Event or Problem · 1

    THE CUSTOMER DISCONTINUED USE OF THE HOMECHOICE (HC) MACHINE AND RETURNED IT TO BAXTER TAMPA BAY. THE PRODUCT ANALYSIS LABORATORY (PAL) DETERMINED THE HC MACHINE SYSTEM FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO A GROUND BOND FAILED PERFORMANCE SPECIFICATION.

    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