BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3142887 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14104
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 12, 2013
    Report Date
    May 12, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS NOT AVAILABLE; THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. USE ERROR AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE" WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE WARNS THE USER NOT TO REPLACE EMPTY SOLUTION BAGS OR RECONNECT DISCONNECTED SOLUTION BAGS DURING THERAPY. IT ALSO WARNS THE USER THAT POSSIBLE CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF DISPOSABLES ARE REUSED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) ENDED THE THERAPY WHILE BEING IN THE MIDDLE OF IT AND PROCEEDED BACK TO START THE THERAPY USING THE SAME SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CARE GIVER (CG) WITH ENDING THE THERAPY AND ADVISED TO START THE THERAPY OVER USING ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR 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
    243146 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE| PD BAGS