BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2110577 · Received June 1, 2011

    Report

    Report Number
    1423500-2011-06923
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 15, 2011
    Report Date
    May 15, 2011
    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 COMPLAINT IS FOR A REPORT OF A USER ERROR. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. COMPLAINT WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USE ERROR. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. 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). THE PRODUCT CODE IS UNKNOWN SO THE 510K NUMBER IS ALSO UNKNOWN.THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER TO REPORT THAT AFTER RECEIVING A CHECK HEATER LINE ALARM IN FILL 1 ON THE HOME CHOICE (HC) THE HP STATED HE ENDED THERAPY AND REPLACED THE CASSETTE AND NOT THE BAGS. THE HP STATED THE HC ALARMED CHECK HEATER LINE IN FILL 1 AGAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INFORMED HP WHEN RESTARTING THE THERAPY OVER WITH NEW SUPPLIES HE NEEDED TO CHANGE OUT THE BAGS AS WELL AS THE CASSETTE. TSR INFORMED HP TO END THE THERAPY AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 HOME CHOICE