BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3202769 · Received July 2, 2013

    Report

    Report Number
    1416980-2013-17035
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 19, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE EVENT HISTORY LOG REVIEW, AN INCREASED INTRA-PERITONEAL VOLUME EVENT WAS IDENTIFIED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE A FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME PERCENT SETTING TOO LOW. THE REVIEW OF THE HOMECHOICE APD SYSTEMS TRAINER'S GUIDE LABELING WAS PERFORMED. SECTION ON "PROGRAMMING A PRESCRIPTION" GIVES THE WARNING THAT "IF YOU SET THE MINIMUM DRAIN VOLUME PERCENT TOO LOW, AN INCOMPLETE DRAIN COULD RESULT FOR THE PATIENT. THIS COULD CAUSE AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) SITUATION." ALSO, THE GUIDE PROVIDES A TABLE CALLED THE NURSE'S MENU SETTINGS, THAT 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)." A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013 23:07:39. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 1536ML, INDICATING THE HOME PATIENT (HP) DRAINED 1536ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2100ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301891 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR