BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1970586 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-01010
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF USER ERROR. THE HOME PATIENT REPLACED THE SUPPLY SOLUTION BAG WITH A NEW ONE BECAUSE IT WAS EMPTY. THIS REPORT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE ROOT CAUSE IS USER ERROR/ MIS-USE. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE REPORT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A CHECK LINES AND BAGS ALARM THE HOME PATIENT (HP) STATED THE SUPPLY BAG WAS EMTPY, SO THEY DISCONNECTED IT AND ADDED A FULL BAG. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) ADVISED THE HP TO RESTART THERAPY WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW-UP, HP CONFIRMED SHE WAS TOLD NOT TO DISCONNECT BAG DURING THERAPY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOME CHOICE CYCLER