BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2001879 · Received February 25, 2011

    Report

    Report Number
    1423500-2011-02463
    Event Type
    Malfunction
    Date Received
    February 25, 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
    US
    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). THIS COMPLAINT IS FOR A REPORT OF A USER ERROR. THE PATIENT CHANGED OUT THE CASSETTE HOWEVER REUSED THE SOLUTION BAGS. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION. PER THE COMPLAINT INFORMATION THE CAUSE OF THE COMPLAINT IS USE ERROR. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK HEATER LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING FILL 1. THE HOME PATIENT (HP) STATED THAT SHE CHANGED THE CASSETTE BUT DID NOT CHANGE THE BAGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT SHE WOULD NEED TO START OVER WITH NEW SUPPLIES. THE HC DEVICE WAS OPERATIONAL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING FOLLOW UP THE HOME PATIENT (HP) STATED THAT HER HOME CHOICE (HC) ALARMED CHECK HEATER LINE AND SHE ONLY CHANGED OUT THE HEATER BAG. THE HP THEN PRESSED GO AND THE HC ALARMED AGAIN. THE HP CALLED GLOBAL TECHNICAL SERVICES AND THEY INSTRUCTED HER TO CHANGE OUT ALL SUPPLIES. THE HP SAID THAT AFTER SHE CHANGED OUT ALL SUPPLIES SHE WAS ABLE TO FINISH THERAPY WITH NO FURTHER PROBLEMS.

    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 63 YR HOMECHOICE CYCLER