BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4152973 · Received October 8, 2014

    Report

    Report Number
    1416980-2014-35046
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVENT INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED A LEAK BETWEEN THE CASSETTE AND THE HEATER BAG ON THE HOMECHOICE DEVICE, DURING DAY DWELL ONE OF ONE. THE HP WAS NOT CONNECTED AT THE TIME OF THE EVENT. THE TUBING DISCONNECTED FROM THE HEATER BAG AND RESULTED IN A FLUID LEAK. DURING TROUBLESHOOTING, THERE WAS NOTHING UNUSUAL NOTED WITH THE SUPPLIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HP TO END THERAPY. 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
    631488 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HOMECHOICE