BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3031739 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08191
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    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. THIS COMPLAINT FOR A REPORT OF AIR IN TUBING (WITHOUT AN ALARM) WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A CHECK PATIENT LINE ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 3 OF 6, AND THE CARE GIVER (CG) STATED THAT THERE WERE LARGE BUBBLES IN THE PATIENT LINE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM AND HAD NOT DISCONNECTED PRIOR. THERE WERE NO OPEN CLAMPS ON UNUSED LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES AND THEY HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE PATIENT LINE HAD BEEN PROPERLY PRIMED. PATIENT EXTENSIONS LINES WERE IN USE, BUT HAD NOT BEEN CONNECTED PRIOR TO PRIME. THE BAGS WERE NOT ALL PROPERLY CONNECTED. THE TSR ASKED IF THERE WERE ANY LEAKS OR WET SPOTS ANYWHERE, AND THERE WERE NOT. THE TSR EXPLAINED THAT THE CG WOULD NEED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR WALKED THE CG THROUGH ENDING THERAPY. 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
    135221 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE