BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3162446 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-14973
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    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). EVALUATION SUMMARY: A VISUAL INSPECTION WAS PERFORMED AND FOUND NO ISSUES. PERFORMANCE TESTING FOUND NO ISSUES WITH THE DEVICE. THE DEVICE MET ALL SPECIFICATIONS. THE DEVICE LOG WAS REVIEWED AND FOUND NO ALARMS OR FAILURE CODES ASSOCIATED WITH THE REPORTED PROBLEM. A REVIEW OF THE SERVICE HISTORY REVEALED NO FAILURES OR PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. A REVIEW OF THE DEVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED. THE INITIAL EVALUATION DID NOT CONFIRM THE REPORTED CONDITION. NO BURNT MARK WAS CONFIRMED ON ANY PARTS. UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BURNT SMELL WAS COMING FROM THE HOMECHOICE (HC) MACHINE DURING USE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262132 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 PD DISPOSABLES