BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2945475 · Received February 6, 2013

    Report

    Report Number
    1416980-2013-03023
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF IIPV - ADULT WAS CONFIRMED. THE ROOT CAUSE WAS -INSUFFICIENT DRAIN - INNAPPROPRIATE SETTING, MINIMUM DRAIN VOLUME PERCENTAGE TOO LOW. THE EVENT HISTORY LOG REVIEW CONFIRMED THE REPORTED PROBLEM. THE MACHINE WAS RECEIVED BY BAXTER, AND A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. ONE HOUR OF THERAPY WAS COMPLETED ON THE HOMECHOICE SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A HIGH DRAIN ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) AFTER THERAPY. THE BAXTER TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ITS CAUSE. THE HOME PATIENT'S (HP) THERAPY WAS SET TO CONTINUOUS CYCLING PERITONEAL DIALYSIS, THE TOTAL VOLUME WAS EQUAL TO 9000ML, THE FILL VOLUME WAS EQUAL TO 2000ML, THE LAST FILL VOLUME WAS EQUAL TO 1000ML, AND THE DEXTROSE WAS SET TO DIFFERENT. THE HP HAD USED A STRONGER DEXTROSE THE PREVIOUS NIGHT AS THE HP WAS RETAINING FLUID. THE TSR CHECKED THE THERAPY LOG. THE TOTAL ULTRAFILTRATION (UF) WAS SET TO 1537ML, THE CYCLE 4 UF WAS SET TO 2092ML, CYCLE 3 UF WAS SET TO 103ML, CYCLE 2 UF WAS SET TO 404ML, AND THE CYCLE 1 UF WAS SET TO 255ML. THERE WERE NO BYPASSES. THE TSR EXPLAINED THAT THE HC MUST BE SET FOR A 75% MINIMUM DRAIN. THE TSR ADVISED THE HP TO CONTACT THEIR REGISTERED NURSE TO EXPLAIN WHAT CAUSED THE HIGH DRAIN ALARM AND SUGGESTED TO SET THE MINIMUM DRAIN TO 85%. THE CALLER WOULD ALSO HAVE THE NURSE PROGRAM THE NEW HOMECHOICE AS THE HP DID NOT HAVE A PROCARD AND THE MACHINE WAS BEING SWAPPED. THERE WAS PATIENT INVOLVEMENT BUT 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
    51164 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1