BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3163622 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-15052
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Removal / Correction Number
    1423500-01/08/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME PERCENT SETTING TOO LOW. THE FOLLOWING LABELING WAS REVIEWED: (B)(4) 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)." IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    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 AT 01:29:35. DURING NIGHT DRAIN CYCLE 4, THE PATIENT'S ULTRAFILTRATION READING WAS 932ML, INDICATING THE HOME PATIENT (HP) DRAINED 932ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1500ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263546 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR