BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3970946 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24813
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, NO EVALUATION COULD BE PERFORMED. PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿ WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE INSTRUCTS THE USER TO CHECK ALL DISPOSABLE SET CONNECTIONS FOR A SECURE FIT BEFORE BEGINNING THERAPY. THE GUIDE ALSO PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY CONNECTING THE SOLUTION BAGS. THE GUIDE WARNS THAT A POSSIBLE CONTAMINATION OF THE FLUID PATHWAY CAN RESULT IF DISPOSABLES ARE REUSED. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN SET/LINE) ALARM OCCURRED ON A HOME CHOICE (HC) DEVICE DURING FILL ONE OF FOUR. THE PATIENT WAS CONNECTED TO THE HOMECHOICE AT THE TIME OF THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THE ALARM AND ASSISTED THE PATIENT IN CLEARING THE ALARM. DURING THE TROUBLESHOOTING, IT WAS DETERMINED THAT THERE WAS A LOOSE CONNECTION ON THE SUPPLY LINE. THE PATIENT WAS TO START THERAPY OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447962 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR HOMECHOICE