BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2073206 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05224
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 14, 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 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THIS PROBLEM WAS THE DEFECT OF THE ACCOMP BOARD. THE ACCOMP BOARD WAS REPLACED AND THE INSTRUMENT MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    TECHNICAL SERVICE CENTER RECEIVED THE ACTUAL SAMPLE FOR REGULAR MAINTENANCE. THE ENGINEER FOUND THE BURNT PART ON THE ACCOMP BOARD DURING MAINTENANCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1