BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3142415 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14064
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    January 27, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IIPV WAS CONFIRMED IN THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME PERCENT SETTING TOO LOW. THE FOLLOWING LABELING WAS REVIEWED: (B)(4) 2010 HOMECHOICE APD SYSTEMS TRAINER'S GUIDE. SECTION 12 "PROGRAMMING A PRESCRIPTION" IN 12.3.3 ON PAGE 12-6 GIVES THE WARNING THAT "IF YOU SET THE MINIMUM DRAIN VOLUME% TOO LOW, AN INCOMPLETE DRAIN COULD RESULT FOR THE PATIENT. THIS COULD CAUSE AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION." ALSO, PAGE 12-7 IN TABLE 2-2 NURSE'S MENU SETTINGS, STATES "THE DEFAULT SETTING OF 85% IS APPROPRIATE FOR PATIENTS WITH LOW TO MODERATE ULTRAFILTRATION RATES (UF PER CYCLE IS LESS THAN OR EQUAL TO 10% OF THE FILL VOLUME). A HIGHER SETTING MAY BE MORE APPROPRIATE FOR PATIENTS WITH HIGHER ULTRAFILTRATION RATES (UF PER CYCLE IS GREATER THAN 10% OF THE FILL VOLUME)." THE LABELING REVIEWED WAS FOUND TO BE SUFFICIENT.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE LOGS OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED AS A HIGH DRAIN 104 ALARM WHICH OCCURRED DURING CYCLE 4. THIS INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. THE DRAIN VOLUME WAS 5007ML, AND THE FILL VOLUME IS 2300ML. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244040 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE