BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3041371 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08728
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME. THE ROOT CAUSE OF THE SYSTEM ERROR 2240 WAS AN OPEN CLAMP ON AN UNUSED LINE, WHICH IS A KNOWN CAUSE OF THIS ALARM. PER BAXTER LABELING, USERS ARE INSTRUCTED THAT CLAMPS ON ANY UNUSED SOLUTION LINES MUST REMAIN CLOSED WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 3. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THERE WAS AN OPEN CLAMP ON AN UNUSED LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE REGISTERED NURSE (RN) CYCLE THE POWER AND THE HC ALARMED SYSTEM ERROR 2367. THE TSR EXPLAINED THE ALARM AND INSTRUCTED THE RN TO SETUP WITH ALL NEW SUPPLIES OR HAVE THE PATIENT PERFORM A MANUAL EXCHANGE. THE RN UNDERSTOOD. THE RN WOULD CONTACT THE PERITONEAL DIALYSIS REGISTERED NURSE TO DETERMINE HOW TO PROCEED. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144169 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE