BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3972132 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24936
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED IN THE EVENT HISTORY LOG REVIEW. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE CAUSE WAS THE TOTAL TIDAL ULTRA FILTRATION (UF) REMOVAL WAS SET TOO LOW. HOMECHOICE APD SYSTEMS TRAINER¿S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 AT 01:09:46. DURING NIGHT DRAIN CYCLE 10, THE PATIENT'S ULTRAFILTRATION READING WAS 1863ML, INDICATING THE HOME PATIENT (HP) DRAINED 1413ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1800ML. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447828 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR