BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3133126 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13567
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 14, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED AND THERE WERE NO ISSUES FOUND. A SIMULATED THERAPY WAS PERFORMED ON THE DEVICE WITHOUT ISSUES. THE REPORTED ISSUE COULD NOT BE CONFIRMED OR DUPLICATED DURING THE EVALUATION OR IN THE DEVICE LOG. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD RECEIVED A LARGER FILL VOLUME, THAN THEIR PRESCRIBED VOLUME. THIS OCCURRED DURING THERAPY, USING A HOMECHOICE (HC) DEVICE. THE VOLUME RECEIVED WAS 202ML AND THEIR PRESCRIBED VOLUME WAS 200ML. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE EVENT WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237575 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 PD DISPOSABLES