BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2243448 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12073
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT IS CONFIRMED DUE TO THE USE ERROR DESCRIBED BY THE HOME PATIENT; THE SUPPLIES WERE REUSED AFTER ENDING THERAPY IN RESPONSE TO A SYSTEM ERROR ALARM. A LABELING REVIEW FOUND THE HOME CHOICE USER MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THIS IS AN INTERNATIONAL REPORT OF A CUSTOMER THAT CALLED PREVIOUSLY TO REPORT A SYSTEM ERROR 2046 AND THEN CALLED BACK AND STATED THAT HE WAS TOLD TO START OVER WITH NEW SUPPLIES. THE HOME PATIENT (HP) STATED INSTEAD, HE STARTED OVER WITH THE SAME SUPPLIES AND HE DIDN'T THINK HE HAD ENOUGH SOLUTION TO START OVER WITH AND NEEDS TO END THE THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO NEVER START OVER WITH THE SAME SET UP AND THEN ASSISTED THE HP TO CYCLE THE POWER OFF/ON, END THE THERAPY AND START OVER WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE