BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2073275 · Received May 1, 2011

    Report

    Report Number
    1423500-2011-05229
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 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). 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. 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).THIS COMPLAINT WAS CONFIRMED THROUGH GLOBAL TECHNICAL SERVICES TROUBLESHOOTING. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. THE CAUSE WAS DETERMINED TO BE A USE ERROR. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING, A CHECK FINAL LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) MACHINE DURING PRIME, THE HOME PATIENT (HP) REVEALED THAT HE HAD STARTED OVER WITH NEW SET AND USED SAME OLD BAGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO STOP SETUP, ADVISED TO START WITH ALL NEW SUPPLIES AND EXPLAINED THAT IT COULD CAUSE CONTAMINATION. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW-UP WITH THE HP, IT WAS FOUND THAT THE HP HAD STARTED OVER WITH ALL NEW SUPPLIES AND WAS ABLE TO CONTINUE WITH THERAPY. THERE IS NO SAMPLE AVAILABLE FOR EVALUATION.

    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 HC CYCLER