BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3232690 · Received July 18, 2013

    Report

    Report Number
    1416980-2013-18797
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING EVALUATION, THE DEVICE WAS WORKING AS INTENDED. AS A RESULT, THE CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS OBSERVED DURING MANUFACTURING OF THIS DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE FOUND NO ISSUES. THE REPORTED CONDITION COULD NOT BE CONFIRMED IN THE EVENT HISTORY LOG. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOMECHOICE (HC) DEVICE HAD AN ISSUE WITH INCORRECT SOLUTION MEASUREMENT. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334530 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1