BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3920131 · Received July 8, 2014

    Report

    Report Number
    1416980-2014-21856
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. THE DEVICE PASSED ELECTRICAL AND FUNCTIONAL TESTING. EXTERNAL AND INTERNAL VISUAL INSPECTIONS WERE PERFORMED AND FOUND NO ISSUES. THE PNEUMATIC SYSTEM WAS TESTED AND FOUND NO ISSUES. A SIMULATED THERAPY WAS PERFORMED ON THE DEVICE SUCCESSFULLY. THE REPORTED ISSUE WAS IDENTIFIED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS A FALSE EMPTY DETECTED AND AN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME PERCENT SETTING TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER'S GUIDE PROVIDES A WARNING "IF YOU SET THE MINIMUM DRAIN VOLUME % TOO LOW, AN INCOMPLETE DRAIN COULD RESULT FOR THE PATIENT. THIS COULD RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION." 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 HIGH DRAIN 105 ALARM OCCURRED DURING DRAIN FIVE ON THE HOME CHOICE (HC). THIS INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED THE RETURN OF THE DEVICE AND DISCUSSED THE USE OF MANUAL SUPPLIES TO COMPLETE THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397121 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR