BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2072956 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05203
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BAXTER TECHNICAL SERVICE CENTER RECEIVED THE ACTUAL SAMPLE FOR EVALUATION. THE ENGINEER CONFIRMED THAT THERE WAS A PROBLEM ON THE J4 CONNECTOR OF THE ACCOMP BOARD AND HEATER PAN. THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THIS PROBLEM WAS FOUND TO BE A DEFECT OF THE J4 CONNECTOR OF THE ACCOMP BOARD AND HEATER PAN. THE J4 CONNECTOR OF THE ACCOMP BOARD AND HEATER PAN WERE REPLACED AND THE INSTRUMENT MET ALL SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A BAXTER ENGINEER FOUND A BURNT PART IN THE HOMECHOICE MACHINE DURING REGULAR MAINTENANCE AT THE TECHNICAL SERVICE CENTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1