BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 2222644 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11225
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K833065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE, THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. THE SAMPLE IS NOT AVAILABLE. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR USE ERROR - FAILED TO FOLLOW THERAPY STEPS WAS CONFIRMED BASED ON CUSTOMER INFORMATION. THE CAUSE WAS UNDETERMINED. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR USE/USER ERROR RELATED TO THIS INCIDENT.

    Description of Event or Problem · 1

    THIS IS A REPORT OF USE ERROR WHERE THE DRAIN LINE EXTENSION FOR THE HOMECHOICE MACHINE WAS REUSED BY THE HOME PATIENT (HP) FOR 3-4 DAYS. DURING TROUBLESHOOTING FOR A CHECK HEATER LINE ALARM, THE BAXTER TECHNICAL REPRESENTATIVE (TSR) RECOMMENDED THE HP CHANGE OUT THE REUSED DRAIN LINE EXTENSION. THE HP WANTED TO END THE THERAPY. THE TSR WALKED THE HP THROUGH ENDING THERAPY PROCEDURES AND ADVISED THE HP TO CALL THEIR REGISTERED NURSE (RN) AND LET THEM KNOW ABOUT ANY MISSED 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
    1 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1