BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3172306 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15497
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN TUBING) ALARM ON THE HOMECHOICE (HC). THIS OCCURRED DURING DRAIN 1 OF 4, WHILE THE HP WAS CONNECTED. THE REGISTERED NURSE (RN) STATED THAT THE HP HAD DISCONNECTED FROM THE HC IN ORDER TO USE THE RESTROOM. THE HC HAD ALARMED RIGHT AFTER THE HP HAD RECONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ASSISTED THE RN WITH CLEARING IT BY CYCLING THE POWER. THE HC ALARMED WITH A SYSTEM ERROR 2367, WHICH WAS A CASCADING ALARM, AND THIS WAS ALSO CLEARED. THE TSR ADVISED THE RN TO START THE THERAPY OVER USING ALL NEW SUPPLIES, AS THE SUPPLIES FROM THE CURRENT SET UP WERE COMPROMISED. THERE WAS NO REPORT OF ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273866 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE