BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1984575 · Received February 11, 2011

    Report

    Report Number
    1423500-2011-01777
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 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 COMPLAINT IS FOR A REPORT OF A USER ERROR. THE PATIENT USED THE SAME SUPPLIES FOR TWO DAYS. THIS COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THIS 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING WITH (B)(4), THE PATIENT EXPLAINED THAT HE USES THE SAME SETUP FOR TWO DAYS. (B)(4) ADVISED THE PATIENT TO CHANGE THE SETUP EVERY DAY. THE PATIENT STATED HE WAS TAUGHT AT THE CLINIC TO SETUP FOR TWO DAYS, AND CHANGE THE SUPPLIES OUT EVERY OTHER DAY. (B)(4) ADVISED IT WAS RECOMMENDED TO START OVER WITH NEW SUPPLIES EVERY DAY. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S DIALYSIS CLINIC. AN UNKNOWN CONTACT CONFIRMED THAT WAS THE WAY THE PATIENT WAS TRAINED AND THAT THERE WAS NO CONTAMINATION ISSUES WHEN USING THE SETUP WITH THE SAME SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)