BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2991061 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05359
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED OVER THE PHONE AND THE ROOT CAUSE WAS DETERMINED TO BE A USE ERROR, THE TIDAL TOTAL UF REMOVAL WAS SET TOO LOW. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION. THE FOLLOWING LABELING WAS REVIEWED: HOMECHOICE APD SYSTEMS TRAINER?S GUIDE AND HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE. "OPERATING INSTRUCTIONS - CHANGE PROGRAM" STATES THIS WARNING "A TOTAL UF VOLUME SET TOO LOW CAN RESULT IN A GRADUAL BUILDUP OF UF VOLUME DURING THE THERAPY. THIS CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION" THE LABELING ALSO STATES "SEVENTY PERCENT (70%) OF YOUR NORMAL NIGHT UF IS A GOOD STARTING POINT FOR DETERMINING YOUR OPTIMUM TOTAL UF."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN INCIDENT OF INCREASED INTRA PERITONEAL VOLUME (IIPV) DURING PERITONEAL DIALYSIS (PD) THERAPY. THIS OCCURED WHILE THE HOME PATIENT (HP) WAS CONNECTED IN DRAIN 5. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) REVIEWED THE DEVICE SETTINGS. THAT DAY THE ULTRAFILTRATION (UF) THROUGH THE LAST CYCLE COMPLETED WAS 2021ML. THE TSR EXPLAINED THAT THERE MIGHT BE A PROGRAM ISSUE FOR THE UF TARGET AFTER THE TSR REVIEWED THE DEVICE LOGS AND NOTICED THE DRAIN CYCLE 5 UF IS ALWAYS HIGH. THE HP UNDERSTOOD THE ISSUE AND WOULD CALL HER NURSE IN THE MORNING. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94976 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1