BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4801952 · Received May 28, 2015

    Report

    Report Number
    1416980-2015-23120
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 13, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT EXPERIENCED DIFFICULTY WHILE TRYING TO ATTACH TUBING DURING PERITONEAL DIALYSIS SET-UP. THE HOME PATIENT WAS LOOKING FOR ANY EASY ASSIST DEVICE THAT WOULD HELP THE PATIENT MAINTAIN INDEPENDENCE IN USING THE PRODUCT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347708 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE