BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 6231182 · Received January 6, 2017

    Report

    Report Number
    1416980-2017-00055
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Date of Event
    December 12, 2016
    Report Date
    February 21, 2017
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTION: CLASSIFICATION CHANGED FROM KDJ - SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE TO FKX - SYSTEM, PERITONEAL, AUTOMATIC DELIVERY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAK NOTED DURING PERITONEAL DIALYSIS THERAPY ON THE HOMECHOICE DEVICE. THE CARE GIVER (CG) REALIZED THAT THERE WAS SOLUTION LEAKING UNDER THE MACHINE. THE CG COULD NOT DETERMINE THE LOCATION OR THE CAUSE OF THE LEAK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13958 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR