BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2200066 · Received August 10, 2011

    Report

    Report Number
    1423500-2011-10517
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    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). THIS REPORT OF A USE ERROR WAS CONFIRMED AND THE CAUSE WAS IDENTIFIED AS THE PATIENT FAILING TO FOLLOW PROPER THERAPY STEP PROCEDURES. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR USE/USER ERROR RELATED TO THIS INCIDENT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510K NUMBER CANNOT BE PROVIDED SINCE THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT AND LOT NUMBER IS 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.

    Description of Event or Problem · 1

    THIS REPORT IS FOR ISSUE OF USE ERROR - HOME PATIENT (HP) REUSES SAME SUPPLIES. DURING TROUBLESHOOTING FOR AN UNRELATED ALARM, THE HP STATED THAT HE HAD A LOT OF ALARMS AND HE STARTED OVER WITH THE SAME SUPPLIES. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) ASKED THE HP IF HE STARTED OVER WITH NEW SUPPLIES. HP STATED NO. TSR EXPLAINED THAT IF THE HP HAS TO START OVER, THE HP WILL HAVE TO START OVER WITH NEW SUPPLIES. TSR RECOMMENDED THAT THE HP CONTACT THE REGISTERED NURSE (RN) . TSR ASSISTED THE HP WITH ENDING THE THERAPY. THERE WAS PATIENT INVOLVEMENT. THERE WAS 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1