BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4213009 · Received October 30, 2014

    Report

    Report Number
    1416980-2014-37977
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED.  AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT 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 SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM OCCURRED DURING DWELL TWO OF THREE ON THE HOMECHOICE (HC). THE HOME PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. THERE WAS NOTHING FOUND DURING TROUBLESHOOTING THAT WOULD CAUSE OR CONTRIBUTE TO THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HOME PATIENT TO CLEAR THE ALARM AND ADVISED TO START OVER WITH NEW SUPPLIES OR COMPLETE THERAPY WITH MANUAL SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696058 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE