BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4032365 · Received August 25, 2014

    Report

    Report Number
    1416980-2014-27835
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    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). (B)(6). AN EVENT HISTORY LOG REVIEW WAS PERFORMED WITH NO ISSUES NOTED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION, AS THE REPORTED CONDITION WAS NOT SPECIFIED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED WITH NO ISSUES NOTED IN THE INITIAL EVALUATIONS. ONE HOUR SIMULATED THERAPY WAS PERFORMED SUCCESSFULLY. CRT(CYCLE REMOTE TEST), FTC(FINAL TEST AND CALIBRATION) AND ELECTRICAL LEAK TEST WERE PERFORMED WITHOUT ANY ISSUES. THE DEVICE OPERATED WITHIN THE DESIRED PRODUCT SPECIFICATIONS. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE OPERATED WITHIN THE DESIRED PRODUCT SPECIFICATIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT REPORTED AN UNSPECIFIED CONDITION HAD OCCURRED WITH THEIR MACHINE. THIS WAS REPORTED TO HAVE OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512950 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1